BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE

    MDR report key: 7066581 · Received November 29, 2017

    Report

    Report Number
    9617032-2017-00230
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    April 22, 2016
    Report Date
    October 30, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903679539
    PMA / PMN Number
    K023331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PHOTOS AND SAMPLES WERE RETURNED FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. RETURNED MATERIALS AND PHOTOS SHOWED REPORTED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6011688. CONCLUSION: THE ROOT CAUSE WAS MOST LIKELY CAUSED BY A TIMING ISSUE ON THE EQUIPMENT WHICH INSERTS THE STOPPER. THIS TENDS TO BE A TRANSIET ISSUE WHICH AFFECTS RELATIVELY FEW ASSEMBLIES AT ANY ONE TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBES HAD BROKEN CAPS. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846052 16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6011688 00382903679539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other