BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 12739500 · Received November 2, 2021

    Report

    Report Number
    9617032-2021-01110
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 6, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 AND NO ISSUES WERE OBSERVED RELATING TO OIL GEL GLOBULES AS ALL SAMPLES MET SPECIFICATIONS. 4 RETAINED TUBES WERE 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 OIL 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 TUBE THERE WAS OIL GEL GLOBULES. IT WAS REPORTED THIS EVENT AFFECTED 2400 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "OIL INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635996 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 0351712 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1