SYRINGE, 10ML SALINE IN 10ML

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6) 2025 "REGISTERED NURSE ATTEMPTED TO FLUSH AN IV AND THE PLUNGER CRACKED, NO FORCE WAS USED, PATIENT WAS UNHARMED, AND THE RN USED ANOTHER FLUSH TO FINISH THE JOB". NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAMPLE WAS REQUESTED FOR EVALUATION. 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 1417592 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

ACCORDING TO THE FACILITY ON (B)(6) 2025 "REGISTERED NURSE ATTEMPTED TO FLUSH AN IV AND THE PLUNGER CRACKED, NO FORCE WAS USED, PATIENT WAS UNHARMED, AND THE RN USED ANOTHER FLUSH TO FINISH THE JOB".