BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ II PLASTIC TUBE WITH LIGHT GREEN BD HEMOGARD??¿ CLOSURE

    MDR report key: 7088220 · Received December 6, 2017

    Report

    Report Number
    9617032-2017-00315
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    July 26, 2016
    Report Date
    January 26, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE OF EVENT. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: NO SAMPLES WERE RETURNED, BUT PHOTOS WERE ATTACHED, SHOWING ONE BROKEN CAP, ON DIRTY EPS TRAY, AND TWO TUBES EACH WITH A MINUTE BLACK FM EITHER INSIDE OR EMBEDDED IN THEIR WALLS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6032991. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ II PLASTIC TUBE WITH LIGHT GREEN BD HEMOGARD??¿ CLOSURE HAD A BROKEN CAP, BLACK FOREIGN MATTER, AND A DIRTY TRAY. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865179 BD VACUTAINER® PST¿ II PLASTIC TUBE WITH LIGHT GREEN BD HEMOGARD??¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6032991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other