BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® GOODWIN SOUND

    MDR report key: 13625905 · Received February 28, 2022

    Report

    Report Number
    1018233-2022-00944
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    August 16, 2021
    Report Date
    February 17, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FBX
    UDI-DI
    00801741047220
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE DID NOT FAIL TO MEET RELEVANT SPECIFICATIONS. AS THE PRODUCT WAS NOT USED ON A PATIENT IT WAS NOT USED FOR DIAGNOSTIC OR TREATMENT PURPOSES. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. ONE, 26 FR SOUND DILATOR WAS RETURNED. NO RUSTING OR DISCOLORATION WAS NOTED. DEVICE MEETS SPECIFICATIONS WHICH STATES, "SURFACE MUST HAVE A MIRROR BRIGHT FINISH". A PHOTO SAMPLE WAS ALSO RETURNED. NO RUST OR DISCOLORATION WAS NOTED. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. LABELING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY HAD ISSUES WITH RUST 042822 AND 042820 AND DISCOLORATION 042816 AND 042814 IN THE LUMEN. IT WAS ALSO STATED UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER FOLLOW UP VIA EMAIL ON 16AUG2021, THE LOT NUMBERS OF THE AFFECTED SOUNDS WHICH ARE MIXED WITH NEW BOX AND NEVER PROCESSED. THE NEW BOX, WHICH WAS PROCESSED INITIALLY, NEVER USED ON PATIENT. THIS WAS THE ONGOING ISSUE FOR THE CUSTOMER AND CONSISTENTLY REPLACING THESE. THE CUSTOMER CHECKED AND VERIFIED INTERNAL PROCESS AND FOLLOW THE IFU VERBATIM, FLUSHING WITH STERILE WATER AT POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS 042824 AND 042826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861462 BARD® GOODWIN SOUND GOODWIN SOUND FBX C.R. BARD, INC. (COVINGTON) -1018233 042812 UNK 00801741047220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other