BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 14336927 · Received May 9, 2022

    Report

    Report Number
    1018233-2022-03481
    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
    00801741030406
    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 DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. THE DEVICE WAS NOT RETURNED

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243256 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER URETHRAL CATHETERIZATION TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772414 NGFZ3767 00801741030406

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other