BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 12698886 · Received October 26, 2021

    Report

    Report Number
    9617032-2021-01098
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 29, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO GEL GLOBULES AS ALL SAMPLES MET SPECIFICATIONS. 4 RETAINED TUBES WERE THEREFORE, DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 1300G FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. THE SUPERNATANTS WERE THEN DECANTED AND EXAMINED UNDER MAGNIFICATION FOR ANY SIGNS OF GEL GLOBULES. NONE WERE FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE GEL GLOBULES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THERE WERE OIL GEL GLOBULES WHICH AF. THIS EVENT OCCURRED 28 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "GEL GLOBULES AND FIBRINE WERE FOUND IN SOME TUBES POST CENTRIFUGATION, DUE TO WHICH THE PROBE OF THE INSTRUMENTS GOT AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593700 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1053017

    Patients

    Seq Age Sex Outcome Treatment
    1