BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PST TUBES, LT. GREEN BD HEMOGARD¿

    MDR report key: 7080520 · Received December 4, 2017

    Report

    Report Number
    1917413-2017-00178
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    March 30, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    00382903679607
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD (B)(6) 2016. RESULTS: A BOX OF SAMPLES WAS RETURNED FOR EVALUATION, APPROX 200 TOTAL. EVALUATED SAMPLE TUBES WERE DRAW TESTED, AND THEN ALLOWED TO SIT TO REVEAL POSSIBLE CREEPAGE ISSUES. TUBES WERE THEN CHECKED AND SHAKEN FOR SHIELD INTEGRITY TO SEE IF STOPPERS WOULD LOOSEN. STOPPER CREEPOUT AND LEAKAGE WAS NOT OBSERVED ON RETURNED EVALUATED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5210996. CONCLUSION: UNCONFIRMED COMPLAINT. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE FOR LOOSE OR LEAKING STOPPERS WITH RETURNED SAMPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL LT. GREEN BD HEMOGARD¿ CLOSURES ARE LOOSE AND/OR LEAKING FROM 13X75 MM, 3.0 ML, BD VACUTAINER® PLUS PLASTIC PST TUBES FOR PLASMA SEPARATION. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859940 BD VACUTAINER® PLUS PST TUBES, LT. GREEN BD HEMOGARD¿ PST SERUM TUBES JKA BECTON, DICKINSON & CO. 5210996 00382903679607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other