Safety concerns with Chinese-made syringes more widespread than initially known | Wilnesh News

U.S. Food and Drug Administration Tuesday warning Plastic syringes made in China sold in the United States have “wider” quality control problems than previously known.

The agency said in a safety advisory that it found three Chinese syringe manufacturers violating FDA regulations.

CNBC has been investigating the issue since November, when FDA initially announced It is reviewing reports of quality and performance issues with these syringes, including leaks and breakage. After CNBC asked the question for months, the agency released a renew Security Communications said its ongoing assessment “has confirmed that quality issues with plastic syringes made in China and their distribution in the United States are more widespread than initially known.”

The FDA stated in a press release that it issued warning letters to three Chinese manufacturers on March 18: Jiangsu Shenli Medical Production Co. Ltda Chinese plastic syringe manufacturer, and Medellin Industrial Co., Ltd. and Sol-Millennium Medical Corporation, two companies that market and distribute plastic syringes made in China in the United States. The letters cite violations related to the sale and distribution of unauthorized Chinese-made plastic syringes that are not approved by the FDA for use in the United States.

In a statement to CNBC in January, the agency wrote that it received more than 4,000 reports of problems with plastic syringes in 2023, adding that the number was not limited to syringes made in China. The agency further wrote that the data had “limitations,” such as “incomplete information in reports” and “potential underreporting.”

As part of a months-long investigation, CNBC reviewed hundreds of accounts of syringe medical device reports (MDRs), which are submissions to the FDA designed to highlight suspected problems or malfunctions related to medical products.

Reports reviewed by CNBC examined manufacturers that recently issued warning letters, and some customers and doctors said they found “foreign body“In a syringe. Others say they have”Multiple needles Breaking in vial while formulating vaccine, “”drug Delivers faster than it should,” and the syringe”cracked,” and other questions. One of Medical device report A customer of Jiangsu Shenli Medical Equipment Manufacturing Co., one of the manufacturers that received the warning letter, reported that the syringe caused “inaccurate vaccine metering.”

The three companies did not immediately respond to CNBC’s request for comment after issuing the warning letters.

According to FDA medical device reporting databaseJiangsu Shenli Medical Products Co., Ltd. and Sol-Millennium Medical Inc. produce plastic syringes for McKesson, a large pharmaceutical manufacturer based in Irving, Texas.

In its notice, The FDA wrote that U.S. suppliers, consumers and health care organizations should “immediately transition” from using plastic syringes made by Jiangsu Kaina Medical Co., Ltd. and unused plastic syringes made by Jiangsu Shenli Medical Manufacturing Co., Ltd. unless “absolutely necessary.” Authorized plastic syringe. As with all other plastic syringes made in China, the agency said they should be used as needed until they can transition to another product and urged users to monitor for defects.

McKesson did not immediately respond to a request for comment.

According to FDA data, in addition to Jiangsu Shenli Medical Products Co., Ltd. and Sol-Millennium Medical Inc., there are other Chinese manufacturers that produce plastic syringes for McKesson.Medical device report also link Anhui Tiankang Medical Technology Co., Ltd., Jiangsu Caina Medical Co., Ltd., Suzhou Linghua Medical Equipment Co., Ltd.and Shanghai Kindly Enterprise Development Group Co., Ltd. to Maxon.

McKesson isn’t the only pharmaceutical giant facing problems with syringes. Cardinal Health and Fresenius Medical Care In the past few months, they have also had a Class 1 recall – the most serious type of recall – of their syringes. According to the recall, variations in the size of Cardinal Health Monoject syringes when used with various pumps have led to issues such as incorrect dosing, treatment delays and pump malfunctions including occlusion alarms and feeding delays. Fresenius recalled its products due to reports of leaking syringes and the presence of an unknown black substance inside the syringes, the FDA said.

In a statement to CNBC, the FDA said it believes the supply and manufacturing capacity of plastic syringes made in countries other than China, including the United States, is sufficient to make up for the shortage. The agency also said it would continue to evaluate problems with Chinese-made syringes.