BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 12513667 · Received September 22, 2021

    Report

    Report Number
    1024879-2021-00652
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 27, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678155
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED TWENTY-FIVE (25) SAMPLES FOR INVESTIGATION FROM LOT # 1071565. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR SAMPLE LEAKAGE/POOLING AT THE TOP OF THE STOPPER WITH THE INCIDENT LOT WAS NOT OBSERVED. ALL TWENTY-FIVE (25) SAMPLES PASSED THE FUNCTIONAL TESTING WITH NO DEFECTS IDENTIFIED. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY FROM LOT # 0335174 WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO SAMPLE LEAKAGE/POOLING AT THE TOP OF THE STOPPER AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, 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 OF SAMPLE LEAKAGE/POOLING AT THE TOP OF THE STOPPER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER EXPERIENCED LEAKAGE. WE PURCHASED 6 ML BD VACUTAINER RED TOP TUBES FROM YOU THIS YEAR (PO IN SUBJECT LINE) AND WE HAVE BEEN EXPERIENCING TUBE LEAKS FOR URINE AND VITREOUS HUMOR COLLECTED SPECIMENS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0335174, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2020-11-30. MEDICAL DEVICE LOT #: 1071565, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2021-03-12. 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 WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED CUSTOMER EXPERIENCED LEAKAGE. WE PURCHASED 6 ML BD VACUTAINER RED TOP TUBES FROM YOU THIS YEAR (PO IN SUBJECT LINE) AND WE HAVE BEEN EXPERIENCING TUBE LEAKS FOR URINE AND VITREOUS HUMOR COLLECTED SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408943 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367815 SEE H.10. 50382903678155

    Patients

    Seq Age Sex Outcome Treatment
    1