BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 10097369 · Received May 28, 2020

    Report

    Report Number
    9617032-2020-00444
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 9, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER ON THE SHIELD WITH THE INCIDENT LOT WAS OBSERVED. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER THAT LOOKS "MOLDY" WAS DISCOVER ON SHIED WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BEFORE USE, THE CUSTOMER FOUND 1EA TUBE SHIELD HAS FM ON IT, IT LOOKS MOLDY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER THAT LOOKS "MOLDY" WAS DISCOVER ON SHIED WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BEFORE USE, THE CUSTOMER FOUND 1EA TUBE SHIELD HAS FM ON IT, IT LOOKS MOLDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558576 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9227678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other