BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER

    MDR report key: 14336926 · Received May 9, 2022

    Report

    Report Number
    1018233-2022-03482
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 18, 2022
    Report Date
    July 28, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030437
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿INCORRECT OPERATION". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE URETHERAL CATHETER TRAY HAD THE STERILE GLOVES LOCATED UNDER THE DRAPE WHICH AS A RESULT ONE WAS UNABLE TO STERIALLY PLACE THE DRAPE UNLESS THE NURSE GRABBED OWN SET OF GLOVES (MATERIAL# 772414-LOT# (B)(4). CUSTOMER HAD THREE TRAYS THAT HAVE BEEN LIKE THIS SO FAR THE WAY IT WAS PACKAGED (MATERIAL# 772417-LOT# UNK).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE URETHERAL CATHETER TRAY HAD THE STERILE GLOVES LOCATED UNDER THE DRAPE WHICH AS A RESULT ONE WAS UNABLE TO STERIALLY PLACE THE DRAPE UNLESS THE NURSE GRABBED OWN SET OF GLOVES (MATERIAL# 772414-LOT# NGFZ3767). CUSTOMER HAD THREE TRAYS THAT HAVE BEEN LIKE THIS SO FAR THE WAY IT WAS PACKAGED (MATERIAL# 772417-LOT# UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243255 BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER URETERAL TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772417 UNK 00801741030437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other