BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 7475737 · Received May 1, 2018

    Report

    Report Number
    1917413-2018-02647
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    January 17, 2017
    Report Date
    April 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6064613, MEDICAL DEVICE EXPIRATION DATE: 03/31/2017, DEVICE MANUFACTURE DATE: 03/04/2016, MEDICAL DEVICE LOT #: 6090532, MEDICAL DEVICE EXPIRATION DATE: 04/30/2017, DEVICE MANUFACTURE DATE: 03/30/2016, MEDICAL DEVICE LOT #: 6090533, MEDICAL DEVICE EXPIRATION DATE: 04/30/2017, DEVICE MANUFACTURE DATE: 03/30/2016, MEDICAL DEVICE LOT #: 6124914, MEDICAL DEVICE EXPIRATION DATE: 05/31/2017, DEVICE MANUFACTURE DATE: 05/03/2016, MEDICAL DEVICE LOT #: 6187581, MEDICAL DEVICE EXPIRATION DATE: 07/31/2017, DEVICE MANUFACTURE DATE: 07/05/2016, MEDICAL DEVICE LOT #: 6064610, MEDICAL DEVICE EXPIRATION DATE: 08/31/2017, DEVICE MANUFACTURE DATE: 08/03/2016, MEDICAL DEVICE LOT #: 6253547, MEDICAL DEVICE EXPIRATION DATE: 09/30/2017, DEVICE MANUFACTURE DATE: 09/09/2016, BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. 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® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAD GEL ASPIRATING INTO THE PROBE AND CAUSING ERRORS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318367 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6216624 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Other