BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 15921236 · Received December 5, 2022

    Report

    Report Number
    1911916-2022-00702
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    September 5, 2022
    Report Date
    November 29, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    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 1232334. 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. 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 EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DUE TO "INTERMITTENT TENDERNESS OF THE WHOLE ABDOMEN FOR 20 DAYS". AFTER ADMISSION, INTRAVENOUS INFUSION THERAPY WAS GIVEN, AND AN INTRAVENOUS INDWELLING NEEDLE WAS USED. BEFORE ROUTINE INTRAVENOUS INFUSION, A FLUSH WAS REQUIRED TO FLUSH THE TUBE. DURING THE FLUSHING PROCESS, IT WAS FOUND THAT THE FLUSH WAS BROKEN, RESULTING IN FLUID LEAKAGE, WHICH MADE IT IMPOSSIBLE TO CONTINUE TO USE IT, INCREASING THE BURDEN ON NURSES. REPLACED THE PRE-FLUSH CATHETER FLUSHER IMMEDIATELY AFTER DISCOVERY, CONTINUED TO COMPLETE THE OPERATION, AND PROLONGED THE OPERATION TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535467 BD POSIFLUSH¿ SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1232334

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown