BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ACD SOLUTION A BLOOD COLLECTION TUBES

    MDR report key: 10593327 · Received September 28, 2020

    Report

    Report Number
    1917413-2020-00873
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    June 24, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903646062
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 6 PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED IN LOT NUMBER 9126920. THE WHITE SUBSTANCE IN THE TUBE COULD NOT BE IDENTIFIED WITHOUT THE ACTUAL SAMPLE. THE OTHER LOT NUMBER PHOTOS WERE REVIEWED AND THE BROWN SUBSTANCE ON THE TUBES WAS DETERMINED TO BE DRIED ADDITIVE FROM A DAMAGED TUBE WITHIN THE PACKAGE. WHEN THE ADDITIVE LEAKS AND DRIES IT TURNS A DARK BROWN IN COLOR. 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 WITH A BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES FOREIGN MATTER WAS DISCOVERED IN TUBES. THERE WERE 3 INSTANCES WITH LOT# 9065711 AND 9126920, AND 2 INSTANCES WITH LOT# 9280679, AND ONLY 1 WITH LOT# 9220397 AND 9004545. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BROWN STAINS ARE OBSERVED ON ACD TUBES AND BOXES. WHITE MATERIAL FLOATING IN TUBE. FOR LOT# 9126920.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9065711, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2019-03-06, MEDICAL DEVICE LOT #: 9126920, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2019-05-06, MEDICAL DEVICE LOT #: 9280679, MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2019-10-07, MEDICAL DEVICE LOT #: 9220397, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2019-08-08, MEDICAL DEVICE LOT #: 9004545, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2019-01-04". A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH A BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES FOREIGN MATTER WAS DISCOVERED IN TUBES. THERE WERE 3 INSTANCES WITH LOT# 9065711, AND 9126920, AND 2 INSTANCES WITH LOT# 9280679, AND ONLY 1 WITH LOT# 9220397, AND 9004545. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BROWN STAINS ARE OBSERVED ON ACD TUBES AND BOXES. WHITE MATERIAL FLOATING IN TUBE. FOR LOT# 9126920.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059440 BD VACUTAINER ACD SOLUTION A BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 364606 SEE H.10 50382903646062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other