BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 7060283 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00521
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 18, 2016
    Report Date
    October 25, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - 56 SAMPLES WERE RECEIVED FOR EVALUATION. ALL 56 SAMPLES WERE TESTED UNDER PRESSURIZED CONDITIONS FOR LEAKAGE IN TUBING AND HUBS. THERE WAS NO LEAKAGE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6132861. CONCLUSION - WE ARE UNABLE TO CONFIRM THE COMPLAINT AS WE WERE UNABLE TO DUPLICATE THE CUSTOMER'S' INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND LUER ADAPTER HAD LEAKAGE OF BLOOD FROM THE TUBING INSIDE THE PLASTIC HUB. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841088 23 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6132861 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other