BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7533562 · Received May 22, 2018

    Report

    Report Number
    2243072-2018-00817
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    March 17, 2017
    Report Date
    June 11, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE: UPDATED TO INDICATE CORRECT DEVICE TYPE JKA. PMA / 510(K)#: UPDATED TO INDICATE CORRECT 510(K) NUMBER K101502.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) AN OEM MANUFACTURING SITE. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 160906, MEDICAL DEVICE EXPIRATION DATE: 2017-11-30, DEVICE MANUFACTURE DATE: 2016-11-16. MEDICAL DEVICE LOT #: 161106, MEDICAL DEVICE EXPIRATION DATE: 2018-01-31, DEVICE MANUFACTURE DATE: 2017-01-06. MEDICAL DEVICE LOT #: 160906, MEDICAL DEVICE EXPIRATION DATE: 2017-11-30, DEVICE MANUFACTURE DATE: 2017-11-30. BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN HAD POOR SEPARATOR MOVEMENT AND RED CELL HANG UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376943 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 161106 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other