MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER CONTACT, "THE MANIFOLD CONNECTION WITH THE SYRINGE WAS NOT WORKING. SYRINGE DID NOT CONNECT PROPERLY TO MANIFOLD. DELAY IN STARTING PROCEDURE WITH NEW MANIFOLD 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

ACCORDING TO THE CUSTOMER CONTACT, "THE MANIFOLD CONNECTION WITH THE SYRINGE WAS NOT WORKING. SYRINGE DID NOT CONNECT PROPERLY TO MANIFOLD. DELAY IN STARTING PROCEDURE WITH NEW MANIFOLD OPENED".

Additional Manufacturer Narrative

UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D). UPDATE TO H7: IF REMEDIAL ACTION INITIATED, CHECK TYPE. UPDATE TO H9: IF ACTION REPORTED TO FDA UNDER 21 USC 360I(G), LIST CORRECTION/REMOVAL REPORTING NUMBER.