TRAY ESI 20G NDL,PLASTIC LOR,W/PHARM

Additional Manufacturer Narrative

IT WAS REPORTED THAT "LOSS OF RESISTANCE SYRINGE CONCERN". NO INJURY OR MEDICAL INTERVENTION WAS REPORTED BUT A DIFFERENT DEVICE WAS USED. 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)(4) 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

RESISTANCE OF SYRINGE.