BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7113118 · Received December 13, 2017

    Report

    Report Number
    9617032-2017-00658
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    March 9, 2017
    Report Date
    December 12, 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

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: NO SAMPLE WAS RECEIVED FROM THE CUSTOMER AT THE TIME OF THIS REPORT, HOWEVER PHOTOGRAPHS WERE ATTACHED ILLUSTRATING THE REPORTED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PLASTIC URINE COLLECTION CUPS WERE SCRATCHED, HAVE TRACES AND DON'T CLOSE CORRECTLY. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890901 BD VACUTAINER® PLASTIC URINE COLLECTION CUP URINE COLLECTION CUP JTW BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other