SYRINGE, 10ML SALINE IN 10ML

Description of Event or Problem

ACCORDING TO THE FACILITY THE SYRINGE IS DIFFICULT TO USE AND THE "PULL BACK IS TOO LOOSE, MAKES IT IMPOSSIBLE TO REMOVE BUBBLES".

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY THE SYRINGE IS DIFFICULT TO USE AND THE "PULL BACK IS TOO LOOSE, MAKES IT IMPOSSIBLE TO REMOVE BUBBLES". 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.