BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 9140875 · Received October 1, 2019

    Report

    Report Number
    9617032-2019-01111
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR COLLAPSED TUBES WITH THE INCIDENT LOT WAS OBSERVED. HOWEVER, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. NOTE THAT THERE ARE POTENTIALLY VARYING DEGREES OF TUBE COLLAPSE, BASED ON THE TEMPERATURE AND DURATION OF TIME AT ELEVATED TEMPERATURE. MILDLY COLLAPSED TUBES WILL RETAIN VACUUM AND ONLY SHOW MINIMAL DEFORMATION. MILDLY COLLAPSED TUBES WILL DRAW APPROPRIATELY, BUT MAY NOT BE ABLE TO BE PROCESSED ON LABORATORY INSTRUMENTS (E.G. MAY BE SLIGHTLY BOWED AND NO LONGER FIT IN A RACK). AS LONG AS THE VACUUM IS RETAINED AND THE TUBE FILLS APPROPRIATELY, THE TUBE WILL FUNCTION PROPERLY. FULLY COLLAPSED TUBES APPEAR FLATTENED, TWISTED, AND VISIBLY DEFORMED. FULLY COLLAPSED TUBES RETAIN LITTLE OR NO VACUUM AND THEREFORE CANNOT BE DRAWN TO AN APPRECIABLE VOLUME. THESE TUBES ARE EASILY IDENTIFIED BEFORE USE BY THE HEALTHCARE WORKER, SO THERE IS NO POTENTIAL IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 66 BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES EXPERIENCED TUBES/EXTENDERS WITH MOLDING DEFECTS THAT CAN BE USED. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DENTED 9063509 AND 9008744.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9063509. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2019-03-04. MEDICAL DEVICE LOT #: 9008744. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2019-01-08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 66 BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES EXPERIENCED TUBES/EXTENDERS WITH MOLDING DEFECTS THAT CAN BE USED. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DENTED 9063509 AND 9008744.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937512 BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other