BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 18813171 · Received February 29, 2024

    Report

    Report Number
    9617032-2024-00265
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 7, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    OIB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. RETAIN SAMPLE EVALUATION IS NOT AVAILABLE FOR THIS PRODUCT. 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 LEAKAGE, 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® URINE COLLECTION CUPS THAT SAMPLES WERE LEAKING. THIS OCCURRED TWENTY-FIVE (25) TIMES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298264 BD VACUTAINER® URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER OIB BECTON, DICKINSON AND COMPANY (BD) 3311209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown