BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 10920490 · Received November 30, 2020

    Report

    Report Number
    1917413-2020-01194
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY 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 DAMAGED TUBE 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES A MOLDING DEFECT WAS DISCOVERED ON INSIDE OF TUBE WALL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A MOLDING DEFECT WITH VACUTAINERS.

    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 #: 0100272, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2020-04-09, MEDICAL DEVICE LOT #: 0133344, MEDICAL DEVICE EXPIRATION DATE: 2021-09-30, DEVICE MANUFACTURE DATE: 2020-05-12. 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 DURING USE WITH BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES A MOLDING DEFECT WAS DISCOVERED ON INSIDE OF TUBE WALL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A MOLDING DEFECT WITH VACUTAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387181 BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367861 SEE H.10 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1