BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML. GOLD BD HEMOGARD¿ CLOSURE

    MDR report key: 7058800 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00800
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    December 16, 2015
    Report Date
    November 8, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED TO MANUFACTURER ON: UNSPECIFIED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: BD REPRESENTATIVE IN (B)(4) RECEIVED AND EVALUATED TWO SAMPLES THEN SENT PHOTOS OF SAMPLES TO BD. BD RECEIVED PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR REDUCED GEL WITH THE INCIDENT LOT WAS OBSERVED. BASE ON THE PHOTO, THE PIVOT ROD IS BROKEN OFF IN THE HOOK OF THE C COLLAR. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT # 5201694 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: THE ABSOLUTE ROOT CAUSE IS INDETERMINATE. THE MOST LIKELY CAUSE IS A VALVE FAILURE AT THE GEL DISPENSE OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEL WAS NOT ENOUGH IN BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML. GOLD BD HEMOGARD¿ CLOSURE AND COULD NOT SEPARATE THE SERUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838763 BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML. GOLD BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5201694

    Patients

    Seq Age Sex Outcome Treatment
    1 Other