MEDLINE

Additional Manufacturer Narrative

UPDATE TO H6 AND H7. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE INVESTIGATION INVOLVED AN ANALYSIS OF PRODUCTION RECORDS AND CONFIRMATION THAT THE DEVICE WAS NOT RETURNED. A MANUFACTURING PROCESS PROBLEM WAS IDENTIFIED, AND THE CAUSE HAS BEEN TRACED TO A MANUFACTURING DEFICIENCY. THIS ISSUE HAS BEEN IDENTIFIED AS RELATED TO MEDLINE RECALL R-26-025. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING "SET UP FOR PREPARATION FOR STEMI (EMERGENCY) PATIENT, SYRINGE AND MANIFOLD WOULD NOT CONNECT PROPERLY AND SYRINGE WAS SCREWING BACK ON ITSELF DELAYING SET UP." A "NEW HAND INJECTION PACK OPENED". 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

IT WAS REPORTED THAT DURING "SET UP FOR PREPARATION FOR STEMI (EMERGENCY) PATIENT, SYRINGE AND MANIFOLD WOULD NOT CONNECT PROPERLY AND SYRINGE WAS SCREWING BACK ON ITSELF DELAYING SET UP." A "NEW HAND INJECTION PACK OPENED".