BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7095684 · Received December 7, 2017

    Report

    Report Number
    9617032-2017-00482
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    June 15, 2017
    Report Date
    November 16, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. BD HAD NOT RECEIVED ANY SAMPLE OR PHOTO FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. FURTHER INVESTIGATION ACTIVITIES WERE CONDUCTED, AND A POTENTIAL ROOT CAUSE HAS BEEN IDENTIFIED. ALTHOUGH NO ISSUES WERE IDENTIFIED WITHIN THE DHR, EXAMINATION OF THE PROCESSING EQUIPMENT WHICH TIGHTENS THE LID TO THE CUP DETERMINED THAT THE ALIGNMENT OF THE TORQUE STATION WAS INCORRECT. THIS PREVENTED THE CAPS FROM BEING SECURELY ATTACHED TO THE CUPS IN SOME CASES. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FROM THE EXAMINATION OF THE PROCESSING EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VACUTAINER® PLASTIC URINE COLLECTION CUP HAD A LID THAT WAS NOT PROPERLY SCREWED ON. CUSTOMER WORRIED ABOUT THE CUP STERILITY (AS MEANT TO BE STERILE INSIDE). THERE WAS NO REPORT OF SERIOUS INJURY OR MEDIAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877388 BD VACUTAINER® PLASTIC URINE COLLECTION CUP URINE COLLECTION SET JTW BECTON, DICKINSON AND COMPANY (BD) 7083805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other