BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® GOODWIN SOUND

    MDR report key: 13635899 · Received March 1, 2022

    Report

    Report Number
    1018233-2022-00953
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 4, 2022
    Report Date
    April 20, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FBX
    UDI-DI
    00801741047299
    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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    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 PER THE VISUAL REQUIREMENTS WHICH STATES "SURFACE MUST HAVE A MIRROR BRIGHT FINISH". 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. 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. H3 OTHER TEXT : 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 CONSISTENTLY HAD ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. ALSO STATED THAT UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER NOTIFICATION FROM INVESTIGATOR ON 03FEB2022 BASED ON SAMPLE RETURNED, IT WAS REPORTED THAT THE DILATION CATHETERS WERE CORRODED.

    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 CONSISTENTLY HAD ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. ALSO STATED THAT UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER NOTIFICATION FROM INVESTIGATOR ON 04FEB2022 BASED ON SAMPLE RETURNED , THE ADDITIONAL RECORDS WERE CREATED BASED ON THE MATERIAL NUMBERS OF THE SAMPLES RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012566 BARD® GOODWIN SOUND DILATION CATHETER FBX C.R. BARD, INC. (COVINGTON) -1018233 042826 UNK 00801741047299

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other