BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7087172 · Received December 6, 2017

    Report

    Report Number
    9617032-2017-00592
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    February 15, 2017
    Report Date
    January 26, 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

    (B)(4). THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT 510K NUMBER. IT IS CORRECTED TO READ K022426.

    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 LEAKAGE WITH THE INCIDENT LOT WAS VISUALLY OBSERVED. THE LEAKAGE APPEARED TO HAVE BEEN CAUSED BY THE END CAP NOT BEING COMPLETELY ENGAGED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION - BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE EXAMINATION OF THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE HAD LEAKAGE DURING TRANSPORT. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867514 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE SYRINGE WITH NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) 6125818

    Patients

    Seq Age Sex Outcome Treatment
    1 Other