MEDLINE

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." THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY OR MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. 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."

Additional Manufacturer Narrative

UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS. UPDATE TO H7: REMEDIAL ACTION INITIATED. UPDATE TO H9: RECALL NUMBER.