BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES

    MDR report key: 13027966 · Received December 17, 2021

    Report

    Report Number
    9617032-2021-01299
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 29, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMH
    UDI-DI
    50382903627252
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT FIVE (5) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER CORING WITH THE INCIDENT LOT WAS NOT OBSERVED. THREE (3) PHOTOS SHOW THE TESTING EQUIPMENT AND THE OTHER TWO (2 ) PHOTOS SHOW UNUSED TUBES. ADDITIONALLY, TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE TAKEN, DRAWN WITH WATER AND NO ISSUES WERE OBSERVED RELATING TO STOPPER CORING AS ALL SAMPLES MET SPECIFICATIONS. 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 NOTIFICATIONS. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF STOPPER CORING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED A CLOGGED/BLOCKED INSTRUMENTATION PROBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SPA III QUICK CONNECTOR TO THE FILTER WASTE FILTER IS CLOGGED BECAUSE OF THE STOPPER OF THE TUBES. THE BD SYSTEM SPA III HAS TO CONSTANTLY BE WORKED ON AND UNCLOGGED BY OUR TECHNICAL SERVICE BECAUSE THE QUICK CONNECTOR TO THE WASTE FILTER CLOGS UP BECAUSE OF THE STOPPER OF THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922202 BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER. FMH BECTON, DICKINSON AND COMPANY (BD) 362725 1085023 50382903627252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown