MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER CONTACT, "HAND INJECTION 3 WAY TAP + SYRINGE WERE WELL CONNECTED AT BEGINNING OF CASE THEN SYRINGE STARTED TO BECOME LOOSE AND UNTWIST OFF THE MANIFOLD DURING PCI. MANIFOLD CHANGED BUT STILL ISSUE OCCURRED. ENTIRE KIT CHANGED HOWEVER SAME ISSUE OCCURRED WITH NEW SET." DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER 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. 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 CUSTOMER CONTACT, "HAND INJECTION 3 WAY TAP + SYRINGE WERE WELL CONNECTED AT BEGINNING OF CASE THEN SYRINGE STARTED TO BECOME LOOSE AND UNTWIST OFF THE MANIFOLD DURING PCI. MANIFOLD CHANGED BUT STILL ISSUE OCCURRED. ENTIRE KIT CHANGED HOWEVER SAME ISSUE OCCURRED WITH NEW SET."

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.