SYRINGE, 10ML SALINE IN 10ML

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE LUER TIP ON THE SYRINGE IS LONGER AND THAT IT IS HARDER TO GET RID OF AIR BUBBLES IN THE SYRINGE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(6) ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE LUER TIP ON THE SYRINGE IS LONGER AND THAT IT IS HARDER TO GET RID OF AIR BUBBLES IN THE SYRINGE.