BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 7501202 · Received May 9, 2018

    Report

    Report Number
    2243072-2018-00885
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    October 3, 2017
    Report Date
    June 8, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE IS CORRECTED TO JKA. PMA / 510(K)# IS CORRECTED TO K101502.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. INITIAL REPORTER FACILITY NAME: (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN HAD PROBLEMS WITH TUBE PUSHOFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342563 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 170410 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other