DBD-PICC LINE INSERTION PACK

Description of Event or Problem

IT WAS REPORTED THAT A SYRINGE COMPONENT WAS FOUND TO BE BROKEN WITHIN THE PACK.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A SYRINGE COMPONENT WAS FOUND TO BE BROKEN WITHIN THE PACK. NO SERIOUS INJURY OR ADVERSE IMPACT TO A PROCEDURE, PATIENT, OR USER WAS ORIGINALLY REPORTED. 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. A PHOTO WAS PROVIDED FOR REVIEW AND THE REPORTED PROBLEM/ISSUE WAS CONFIRMED. IN THE PHOTO, THE SYRINGE PLUNGER WAS OBSERVED TO BE BENT AND CRACKED. NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR (B)(4) ON (B)(6)2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.