BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 15785567 · Received November 12, 2022

    Report

    Report Number
    1911916-2022-00622
    Event Type
    Malfunction
    Date Received
    November 12, 2022
    Date of Event
    September 23, 2022
    Report Date
    November 7, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065943
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 1172791. 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. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SYRINGE BARREL WAS FOUND DAMAGED AFTER REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: WHEN A NURSE IN THE CHINESE MEDICINE DEPARTMENT USED A PREFILLED CATHETER IRRIGATOR TO GIVE A PATIENT AN INTRAVENOUS BOLUS, WHEN HE OPENED THE PACKAGE, HE FOUND THAT THE HANDLE OF THE PREFILLED CATHETER IRRIGATOR WAS BROKEN AND COULD NOT BE OPERATED, SO IT WAS REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757633 BD POSIFLUSH¿ SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1172791 00382903065943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown