NAMIC

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, THE SYRINGE WAS UNTHREADING FROM THE MANIFOLD EVEN THOUGH IT WAS FIRMLY ATTACHED. THEY HAD TO OPEN A NEW HAND INJECTION KIT IN THE MIDDLE OF THE PROCEDURE. THE FACILITY STATES THIS PUTS THE PATIENT AT RISK FOR AIR EMBOLUS, HOWEVER NO INJURY OCCURRED AND NO MEDICAL INTERVENTION REQUIRED DUE TO THIS MALFUNCTION. ONLY A 5-10 PROCEDURAL DELAY TO OPEN A NEW KIT WAS REPORTED. NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, THE SYRINGE WAS UNTHREADING FROM THE MANIFOLD EVEN THOUGH IT WAS FIRMLY ATTACHED.

Additional Manufacturer Narrative

UPDATED D9: DEVICE AVAILABLE FOR EVALUATION AND DATE RETURNED TO MANUFACTURER , UPDATED H3: DEVICE EVALUATED BY MANUFACTURER, UPDATED H6: TYPE OF INVESTIGATION (B) , UPDATED H6: INVESTIGATION FINDINGS (C) , UPDATED H6: INVESTIGATION CONCLUSIONS (D) , UPDATED H7: IF REMEDIAL ACTION INITIATED, CHECK TYPE, UPDATED H9: IF ACTION REPORTED TO FDA UNDER 21 USC 360I(G), LIST CORRECTION/REMOVAL REPORTING NUMBER R-26-025.