BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 17928064 · Received October 12, 2023

    Report

    Report Number
    1917413-2023-01015
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3136158. D4. MEDICAL DEVICE EXPIRATION DATE: 30-09-2024. H4. DEVICE MANUFACTURE DATE: 16-05-2023. H.6. INVESTIGATION SUMMARY: MATERIAL #: 367856. LOT/BATCH #: 3136158, 3111811. BD HAD NOT RECEIVED SAMPLES, BUT EIGHT (8) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DAMAGE TO THE INSIDE TUBE WALL WAS OBSERVED. AN INDENTATION THAT APPEARED TO HAVE PLASTIC PEELING OFF THE INSIDE WALL WAS OBSERVED. ADDITIONALLY, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF DAMAGED TUBE 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF DAMAGED TUBE BASED ON PHOTOS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE MANUFACTURING PROCESS DOES NOT HAVE ANYTHING INTRODUCED TO THE INSIDE OF THE TUBE THAT WOULD CAUSE THIS TYPE OF DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, THERE WAS FOREIGN MATERIAL FOUND IN AN UNSPECIFIED NUMBER OF TUBES ACROSS TWO LOT NUMBERS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT A PIECE OF PLASTIC FROM THE TUBES IS INTERFERING ON THEIR INSTRUMENT FOR AUTOMATIC TESTING. LOT#: 3136158, LOT#: 3111811."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586235 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3111811 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown