MEDLINE

Description of Event or Problem

SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD. AS SOON AS THE SYRINGE WAS FILLED WITH CONTRAST IT WOULD TWIST OFF WHICH WOULD ALLOW AIR INTO THE SYSTEM. HAD TO CHANGE TO A NEW KIT.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE "SYRINGE WOULD NOT STAY ATTACHED TO THE MANIFOLD. AS SOON AS THE SYRINGE WAS FILLED WITH CONTRAST IT WOULD TWISTOFF WHICH WOULD ALLOW AIR INTO THE SYSTEM." THE CUSTOMER DID NOT REPORTANY PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. DESPITE MULTIPLEGOOD 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 (B)(4) 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.

Additional Manufacturer Narrative

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