FDA Investigating Chinese-Made Syringes Due to Defect, Leak Concerns

Federal regulators are investigating reports of Chinese plastic syringes leaking, breaking, and suffering other quality issues that may affect the administering of medications and treatments.

The U.S. Food and Drug Administration (FDA) issued a safety communication on November 30, announcing that the agency is reviewing the problems, and urged consumers not to use syringes made in China while the investigation is continuing.

The investigation stems from changes made to syringe dimensions during production. This has resulted in multiple complaints of leaks, breakage, and other problems, according to FDA investigators.

The problem is not specific to one Chinese manufacturer, but to plastic syringes made in China by several different companies.

Chinese Syringe Investigation

The reported problems can affect the syringe’s ability to deliver the correct dose of medication when used alone or with other medical devices, like an infusion pump.

The FDA is collecting and analyzing data to evaluate the problem and has already determined the issue does not affect glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

FDA investigators plan to test syringes manufactured in China and monitor further reports and ensure corrective actions are taken, including preventing syringes from entering the U.S., if necessary.

In the meantime, the FDA warned patients and healthcare providers should not use syringes made in China. Patients can also use glass, pre-filled syringes, or syringes used for oral or topical purposes in the meantime since they are not affected by the problem.

Consumers can check the manufacturing location of syringes by reviewing the labeling, the outer packaging, or by contacting the supplier.

The agency recommends that consumers who only have syringes manufactured in China may continue to use them until they are able to find suitable alternative syringes, but should closely monitor the syringes during use for leaks, breakage, and other problems.

Problems with an affected syringe should be reported to the FDA’s MedWatch Adverse Event Reporting program.