BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10886795 · Received November 23, 2020

    Report

    Report Number
    1917413-2020-01180
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 3, 2020
    Report Date
    December 2, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/11/2020. H.6. INVESTIGATION: BD RECEIVED 33 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DAMAGED WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONE WITH RETENTION SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR DAMAGED WITH THE INCIDENT LOT WAS OBSERVED HOWEVER, THIS DEFECT IS NOT CAUSED BY ANY MANUFACTURING PROCESS. 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. 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 MOLDING DEFECT IN TUBE WALL WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A MOLDING DEFECT WITH VACUTAINERS. SEEING LAVENDER TUBES WITH PLASTIC STICKING OUT FROM THE INSIDE WALL OF THE TUBE. WE HAVE SEEN TWO OF THESE TUBES, ONE LAST WEEK AND NOW THIS ONE TODAY. WE NOTICED THEM BECAUSE THE XN PIERCER IS HITTING THE PLASTIC AND GIVING US A SAMPLING ERROR. WHEN THE TUBE IS FULL OF BLOOD IT LOOKS LIKE A CLOT ON THE SIDE OF THE TUBE. DUE TO THE LABELS STICKING THE LOT NUMBER IS HARD TO READ.

    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 #: 0100272. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2020-04-09. MEDICAL DEVICE LOT #: 0100274. 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 MOLDING DEFECT IN TUBE WALL WAS DISCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A MOLDING DEFECT WITH VACUTAINERS. SEEING LAVENDER TUBES WITH PLASTIC STICKING OUT FROM THE INSIDE WALL OF THE TUBE. WE HAVE SEEN TWO OF THESE TUBES, ONE LAST WEEK AND NOW THIS ONE TODAY. WE NOTICED THEM BECAUSE THE XN PIERCER IS HITTING THE PLASTIC AND GIVING US A SAMPLING ERROR. WHEN THE TUBE IS FULL OF BLOOD IT LOOKS LIKE A CLOT ON THE SIDE OF THE TUBE. DUE TO THE LABELS STICKING THE LOT NUMBER IS HARD TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353995 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