BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 11971253 · Received June 9, 2021

    Report

    Report Number
    9617032-2021-00610
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER WAS NOT 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 ISSUES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: OUR TECHNICAL PLATFORM IN VIERZON HAS JUST INFORMED ME ONCE AGAIN OF A DEFECT IN EDTA TUBES WITH THE PRESENCE OF EXCRESCENCE INSIDE THE TUBE WHICH PUT THE HAEMATOLOGY AUTOMATONS AT FAULT.

    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 #: 1004559. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2021-01-04. MEDICAL DEVICE LOT #: 1022413. MEDICAL DEVICE EXPIRATION DATE: 2022-0531. DEVICE MANUFACTURE DATE: 2021-01-29 MEDICAL DEVICE LOT #: 1029733. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-01-29. MEDICAL DEVICE LOT #: 1033809. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2021-0202. 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® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: OUR TECHNICAL PLATFORM IN VIERZON HAS JUST INFORMED ME ONCE AGAIN OF A DEFECT IN EDTA TUBES WITH THE PRESENCE OF EXCRESCENCE INSIDE THE TUBE WHICH PUT THE HAEMATOLOGY AUTOMATONS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867706 BD VACUTAINER K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 368861 1004559 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1