BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES

    MDR report key: 18234708 · Received November 29, 2023

    Report

    Report Number
    9617032-2023-01703
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 7, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903678373
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR CAP COLOR VARIATION WITH THE INCIDENT LOT WAS NOT OBSERVED. NO BD PRODUCT WAS DISPLAYED IN THE PHOTO. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO CAP COLOR VARIATION AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CAP COLOR VARIATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES, THE SPECTROMETER USED TO PRESCREEN TUBE COLOR COULDN¿T IDENTIFY CORRECT COLOR. AT BARNET GENERAL HOSPITAL WE FOUND TWO DISTINCT DIFFERENCES IN COLOR OF CAP WHICH REGISTERED A 20 POINT DIFFERENCE ON SPECTROMETER. LIGHTER (OLD) LOT # 2122533 DARKER (NEW) LOT # 3052236.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137105 BD VACUTAINER® CAT PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3052236 30382903678373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown