BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD GOODWIN SOUND

    MDR report key: 10284894 · Received July 16, 2020

    Report

    Report Number
    1018233-2020-04584
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    September 16, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOE
    UDI-DI
    00801741047312
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED HOWEVER THE CAUSE WAS UNKNOWN. A HEYMAN GOODWIN SOUND WAS RETURNED WITHOUT ITS ORIGINAL PACKAGING. RUSTING WAS NOTED NEAR WHERE THE SOUND "FUNNEL" MEETS THE "SHAFT". A POTENTIAL ROOT CAUSE COULD BE DUE TO "MATERIAL SELECTION". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "VISUAL INSPECTION EXAMINE EACH DEVICE FOR CLEANLINESS. IF VISIBLE SOIL REMAINS, REPEAT MANUAL CLEANING INSTRUCTIONS. VERIFY THAT DEVICES ARE FREE OF DEFORMATIONS (E.G. BENT, BROKEN, CORRODED, CRACKED, WORN, OR FRACTURED) THAT MAY IMPACT ITS INTENDED USE. DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DEFECTIVE. FOR DEVICES THAT FAIL VISUAL INSPECTION, HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS FOR DISPOSAL OF BIOHAZARDOUS WASTE. PRODUCTS HAVE BEEN VALIDATED PER THE INSTRUCTIONS PROVIDED. ANY DEVIATIONS MUST BE VALIDATED BY THE USER. STERILIZATION, STORAGE, AND REPLACEMENT DEVICES SHOULD BE STERILIZED IN ACCORDANCE WITH THE MANUFACTURER¿S INSTRUCTIONS USING DYNAMIC-AIR-REMOVAL STEAM STERILIZATION (PRE-VACUUM). DEVICES SHOULD BE CLEAN, DRY, AND DOUBLE-WRAPPED WITH HOSPITAL STERILIZATION WRAP. A STERILIZATION TRAY MAY ALSO BE USED ACCORDING TO THE MANUFACTURER¿S INSTRUCTIONS. STERILIZATION CYCLE PARAMETERS: EXPOSURE TIME 4 MINUTES, EXPOSURE TEMPERATURE 132°C (270°F), AND DRYING TIME 30 MINUTES. ALLOW DEVICE TO COOL TO ROOM TEMPERATURE AFTER STERILIZATION BEFORE HANDLING. ANY DEVIATIONS FROM THE INSTRUCTIONS PROVIDED MUST BE VALIDATED BY THE USER. STORE PRODUCTS IN A DRY AND CLEAN ENVIRONMENT." CORRECTION: D4. H11:SECTION A THROUGH F THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 GOODWIN SOUND DILATORS HAD DETERMINED TO BE RUSTING INSIDE THE LUMEN OF THE SOUND. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2020, THE COMPLAINANT PROVIDED 6 PRODUCT CATALOG NUMBER WITH THE ISSUE, 042822 , 042830 , 042828 , 042820 , 042826 AND 042824 .

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GOODWIN SOUND DILATORS HAD DETERMINED TO BE RUSTING INSIDE THE LUMEN OF THE SOUND. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 24JUN2020, THE COMPLAINANT PROVIDED 6 PRODUCT CATALOG NUMBER WITH THE ISSUE, 042822, 042830, 042828, 042820, 042826 AND 042824.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751313 BARD GOODWIN SOUND HEYMAN-GOODWIN SOUNDS KOE C.R. BARD, INC. (COVINGTON) -1018233 042830 UNK 00801741047312

    Patients

    Seq Age Sex Outcome Treatment
    1