BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES

    MDR report key: 10921443 · Received November 30, 2020

    Report

    Report Number
    1917413-2020-01197
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    UDI-DI
    50382903678636
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT #: 0133360. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. H.4. DEVICE MANUFACTURE DATE: 2020-05-12.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR COLLAPSED TUBES WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. 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 THERE WERE 10 VACUTAINERS WITH MOLDING DEFECTS WITH BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER RECEIVED VACUTAINERS THAT WERE WARPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE 10 VACUTAINERS WITH MOLDING DEFECTS WITH BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER RECEIVED VACUTAINERS THAT WERE WARPED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 0133370 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 10 VACUTAINERS WITH MOLDING DEFECTS WITH BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER RECEIVED VACUTAINERS THAT WERE WARPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386418 BD VACUTAINER K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE GIM BECTON, DICKINSON & CO. (BROKEN BOW) 367863 0133360 50382903678636

    Patients

    Seq Age Sex Outcome Treatment
    1