BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7059501 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00379
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 19, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. RESULTS- BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. THIS IS A DEFECT AT MANUFACTURE BY THE SYRINGE MAKERS, AND IS A COSMETIC DEFECT. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION - THE MOST LIKELY ROOT CAUSE FOR THE REPORTED DEFECT ON THE INSIDE OF THE SYRINGE BARRELS IS THAT THE ¿FM¿ IS ACTUALLY THE CBLH ADDITIVE SPRAYED ON THE WALL OF THE BARREL.

    Additional Manufacturer Narrative · 1

    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 FOREIGN MATTER WAS FOUND ON THE INNER WALL OF THE SYRINGE BARREL OF THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838977 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE SYRINGE WITH NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) 6034559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other