BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE

    MDR report key: 12763756 · Received November 7, 2021

    Report

    Report Number
    1917413-2021-00948
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 10, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    KDT
    PMA / PMN Number
    K790366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 365017. LOT/BATCH #: 1040898. BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE FIRST PHOTO SHOWS A DAMAGED/CRACKED HEMOGARD CLOSURE AS A CRACK CAN BE SEEN ON THE SIDE OF THE HEMOGARD CLOSURE. THE SECOND PHOTO SHOWS THE ADDITIVE ON THE INSIDE OF THE TUBE AND THIS IS THE NORMAL APPEARANCE OF THE SPRAY COAT PATTERN. NO OTHER FOREIGN MATTER CAN BE SEEN IN THE PHOTO OF THE TUBE. 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 NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF DAMAGED/CRACKED HEMOGARD CLOSURE; HOWEVER, UNCONFIRMED FOR DIRT/ADDITIVE ABNORMALITY INSIDE THE TUBE AS THE SPRAY COAT PATTERN IS NORMAL IN APPEARANCE. 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 BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE WAS CRACKED AND CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIR3004395 - BROKEN TUBE CAP. PIR3004396 - THE TUBE SEEMS TO BE DIRTY FROM THE INSIDE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656239 BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON & CO. (BROKEN BOW) 1040898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown