BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7072799 · Received November 30, 2017

    Report

    Report Number
    9617032-2017-00260
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    February 16, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JTW
    PMA / PMN Number
    K790366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: THE SAMPLE WAS RETURNED. AN EVALUATION OF THE SAMPLE CONFIRMED THE COMPLAINT OF THE DEVICE NOT CLOSING PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5342902. CONCLUSION: THE ROOT CAUSE WAS THE RESULT OF A MOULDING DEFECT ON THE THREAD OF THE CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® PLASTIC URINE COLLECTION CUP LID WOULD NOT PROPERLY SCREW SHUT. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852262 BD VACUTAINER® PLASTIC URINE COLLECTION CUP COLLECTION CUP JTW BECTON, DICKINSON AND COMPANY (BD) 5342902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other