BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7006986 · Received November 7, 2017

    Report

    Report Number
    1917413-2017-00230
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    November 16, 2015
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    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: A PHOTO WAS SENT THAT DEMONSTRATED THE ISSUE. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5093593. 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 A BOX OF BD VACUTAINER® PLASTIC URINE COLLECTION CUP HAD BENT CANNULAS AND CRACKED STOPPERS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787631 BD VACUTAINER® PLASTIC URINE COLLECTION CUP COLLECTION CUP JSM BECTON, DICKINSON & CO. 5093593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other