BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7058957 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00568
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 10, 2015
    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

    RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INSUFFICIENT BLOOD FLOW WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INSUFFICIENT BLOOD FLOW WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. FUNCTION TESTING IDENTIFIED THAT INITIALLY ONLY A LITTLE BLOOD WAS DRAWN BUT, ON MOVING THE PLUNGER ROD A LITTLE THE SYRINGE BEGAN TO FILL, PUSHING THE PLUNGER ROD BACK. ROOT CAUSE: THE IMPLICATION OF THE FUNCTION TESTING IS THAT THE POROUS CELLULOSIC PLUG, WHICH ALLOWS AIR TO ESCAPE FROM THE SYRINGE BARREL WHEN USING IN THE PRESET MODE, HAS BECOME BLOCKED. THE PLUG IS DESIGNED TO ALLOW AIR TO VENT UNTIL THE BLOOD ITS IT AND AT THIS POINT THE PLUG SWELLS AND BLOCKS THE VENT STOPPING THE DRAW. IT HAS BEEN KNOWN, IN SOME CASES THAT IF THERE IS EXCESSIVE LUBE IN THE SYRINGE BARREL THIS CAN FIND ITS WAY ONTO THE POROUS PLUG AND BLOCK IT, PREVENTING THE SYRINGE FROM DRAWING IN PESET MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DEVICE TYPE CODE. THE CORRECT DEVICE TYPE CODE IS JKA.. THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. IT IS CORRECTED TO READ K022426.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRESET" SYRINGE WITH ATTACHED NEEDLE ONLY DREW VERY LITTLE BLOOD VOLUME. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838839 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE SYRINGE WITH NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) 5034047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other