BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD URINE CUP

    MDR report key: 13405341 · Received January 31, 2022

    Report

    Report Number
    2243072-2022-00119
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    December 7, 2021
    Report Date
    March 9, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    KDT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED FOR THE MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD URINE CUP, THE DEVICE EXPERIENCED A BROKEN LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: HI, THE TOP RIM OF THE URINE COLLECTION CONTAINER CHIPPED AWAY A LITTLE BIT, AND NOW I CAN¿T HEAR ANY SUCTION NOISES COMING FROM THE MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD URINE CUP, THE DEVICE EXPERIENCED A BROKEN LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: HI, THE TOP RIM OF THE URINE COLLECTION CONTAINER CHIPPED AWAY A LITTLE BIT, AND NOW I CAN¿T HEAR ANY SUCTION NOISES COMING FROM THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752146 UNSPECIFIED BD URINE CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown