BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7097537 · Received December 7, 2017

    Report

    Report Number
    9617032-2017-00285
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    July 15, 2016
    Report Date
    January 29, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. IT IS CORRECTED TO READ K022426.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION AND FOREIGN MATTER WAS CONFIRMED. THE SAMPLES WERE FUNCTIONALLY TESTED AND EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOGGED NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, TEN (10) RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOGGED NEEDLE WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS ABLE TO CONFIRM THE INDICATED FAILURE MODE. THE NEEDLES USED ON THIS DEVICE ARE SUPPLIED SHIELDED BY BD TUAS AND WHILST INCOMING INSPECTION IS CARRIED OUT ON A SAMPLE NO FURTHER INSPECTION IS CARRIED OUT ON THE NEEDLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE HAD NO DRAW DURING BLOOD WITHDRAWAL. FOREIGN MATTER WAS FOUND IN THE NEEDLE HOLE AROUND 5EA IN 500EA HAD SUCH AN ISSUE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874724 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE BLOOD COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5051029

    Patients

    Seq Age Sex Outcome Treatment
    1 Other