BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 2W 10ML 100% SILICONE STR H 20

    MDR report key: 16967224 · Received May 19, 2023

    Report

    Report Number
    8040412-2023-00215
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 2, 2023
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    EZL
    UDI-DI
    04026704308033
    PMA / PMN Number
    K972184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE MANUFACTURING SITE REPORTS: "AS PER RECOMMENDED IN IFU, THE CATHETER SHALL BE CHECKED ON WEEKLY OR PERIODIC BASIS AND THE CATHETER SHALL BE REPLACED AT MAXIMUM OF INDWELLING OF 29 DAYS AND ADVICE OF THE SUPERVISING PHYSICIAN. THE MATERIALS USED TO PRODUCE THE CATHETER WERE TESTED PER EN ISO (B)(4), BIOLOGICAL EVALUATION OF MEDICAL DEVICES. AS REPORTED IN BEV-0035/20, THE CATHETER WAS REPORTED TO FULFILL THE REQUIREMENTS FOR THEIR SPECIFIED CHARACTERISTICS AND PERFORMANCE, UNDER THE INTENDED CONDITIONS AND FOR ITS INTENDED PURPOSE OF USE. AS PER DISCLOSED BY THE CAREGIVER, THE RASHES WERE DEVELOPED FROM THE OVERFLOW OF URINE THAT WAS NOT DRAINED INTO THE COLLECTION BAG. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED AS THE RASHES WERE NOT CAUSE BY THE BIOCOMPATIBILITY OF THE MATERIAL OR THE FUNCTIONALITY OF THE CATHETER USED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PATIENT SAID SHE HAS A RASH AND THE CATHETER KEEPS GETTING CLOGGED DUE TO A UTI. PATIENT ALSO SAID THE TUBING KINKS AND FOLDS AND CAUSES BACK FLOW". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE PATIENT WAS HAVING A LOT OF DISCHARGE CAUSING THE CATHETER TO CLOG. THE [DOCTOR] CHANGED THEM TO THIS CATHETER AND THE CATHETER STARTED KINKING AND SEPARATING FROM THE COLLECTION BAG. THE CAREGIVER STATED THAT THE RASH WAS FROM THE OVERFLOW OF URINE NOT DRAINING INTO THE BAG. [THE PATIENT] IS A QUADRIPLEGIC". THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PATIENT SAID SHE HAS A RASH AND THE CATHETER KEEPS GETTING CLOGGED DUE TO A UTI. PATIENT ALSO SAID THE TUBING KINKS AND FOLDS AND CAUSES BACK FLOW". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE PATIENT WAS HAVING A LOT OF DISCHARGE CAUSING THE CATHETER TO CLOG. THE [DOCTOR] CHANGED THEM TO THIS CATHETER AND THE CATHETER STARTED KINKING AND SEPARATING FROM THE COLLECTION BAG. THE CAREGIVER STATED THAT THE RASH WAS FROM THE OVERFLOW OF URINE NOT DRAINING INTO THE BAG. [THE PATIENT] IS A QUADRIPLEGIC". THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622866 RUSCH 2W 10ML 100% SILICONE STR H 20 CATHETER, RETENTION TYPE, BALL EZL TELEFLEX MEDICAL SDN. BHD. IPN050150 04026704308033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown