BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 18710924 · Received February 15, 2024

    Report

    Report Number
    1911916-2024-00099
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065951
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306595 AND LOT NUMBER 3233687. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. THE NURSE IN THE NEUROSURGERY WARD WAS PREPARING TO SEAL THE PATIENT'S TUBE, TOOK OUT THE PREFILLED CATHETER IRRIGATOR, AND FOUND THAT THERE WAS LEAKAGE IN THE TUBE WALL. AFTER INSPECTION, IT WAS FOUND THAT THERE WAS A CRACK IN THE TUBE WALL CAUSING LEAKAGE, SO SHE IMMEDIATELY DISCARDED IT AND REPLACED THE PREFILLED CATHETER IRRIGATOR TO COMPLETE THE OPERATION.

    Description of Event or Problem · 0

    THE NURSE IN THE NEUROSURGERY WARD WAS PREPARING TO SEAL THE PATIENT'S TUBE, TOOK OUT THE PREFILLED CATHETER IRRIGATOR, AND FOUND THAT THERE WAS LEAKAGE IN THE TUBE WALL. AFTER INSPECTION, IT WAS FOUND THAT THERE WAS A CRACK IN THE TUBE WALL CAUSING LEAKAGE, SO SHE IMMEDIATELY DISCARDED IT AND REPLACED THE PREFILLED CATHETER IRRIGATOR TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086683 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3233687 30382903065951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown