BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER URINE COLLECTION CUP

    MDR report key: 11962661 · Received June 8, 2021

    Report

    Report Number
    9617032-2021-00602
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 13, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JTW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION OF MATERIAL # 364941, BATCH # 9295704. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CLOUDY URINE CUPS WITH THE INCIDENT LOT WAS OBSERVED. THE NORMALLY CLEAR PLASTIC OF THE CUP HAD A CLOUDY APPEARANCE, MAKING IT SLIGHTLY OPAQUE. ALTHOUGH THE CLOUDY NATURE OF THE PLASTIC WAS APPARENT, THIS DEFECT WOULD NOT AFFECT THE EFFICIENCY OF THE DEVICE, IT IS A PURELY COSMETIC FAULT. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO WATER/MOISTURE AROUND THE MOULDING TOOL INVOLVED. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 18 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUPS ARE "CLOUDY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860017 BD VACUTAINER URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER JTW BECTON, DICKINSON AND COMPANY (BD) 9295704

    Patients

    Seq Age Sex Outcome Treatment
    1