BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SP

    MDR report key: 10049386 · Received May 12, 2020

    Report

    Report Number
    3002682307-2020-00153
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION:A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9213637 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE SHELF CARTON WAS OBSERVED MISSING THE PRODUCT INSERT. TO FURTHER INVESTIGATION THIS INCIDENT, OUR QUALITY TEAM OBTAINED TWO RETAINED SAMPLE SHELF CARTONS OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY. BOTH OF THE RETAINED SHELF CARTONS CONTAINED THE PRODUCT INSERT. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM A FAILURE IN THE WEIGHT DETECTION SYSTEM, WHICH ENSURES THE PROPER PRODUCT AND INSERT COUNT, AND A FAILURE IN THE PACKAGING STATION. DUE TO THE CURRENT STRICT PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD POSIFLUSH¿ SP SYRINGES DIDN'T COME WITH A PRODUCT INSERT. THIS WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO LEAFLET".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD POSIFLUSH¿ SP SYRINGES DIDN'T COME WITH A PRODUCT INSERT. THIS WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO LEAFLET".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509782 BD POSIFLUSH¿ SP SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. 9213637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other