BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPG NEURO STRL XRAY STRG 1X3 200/BX

    MDR report key: 18120159 · Received November 13, 2023

    Report

    Report Number
    3011137372-2023-00249
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    November 6, 2023
    Report Date
    November 6, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EFQ
    UDI-DI
    04026704417506
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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). ADDITIONAL INFORMATION RECEIVED ON 13 NOV 2023 STATES THE DEFECT WAS FOUND "WHEN CUSTOMER WAS PRE-MOISTENING THE SPONGES PRIOR TO USE ON PATIENT". THE SAMPLE WAS RETURNED TO THE MANUFACTURER (CARWILD CORPORATION) FOR INVESTIGATION. CARWILD REPORTS: "THE INVESTIGATION WAS BASED ON THE REVIEW OF DHR, MANUFACTURING PROCEDURES, HISTORICAL COMPLAINT AND TRAINING RECORDS, AND NO FINDINGS WERE FOUND. SAMPLES THAT WERE PROVIDED SHOWED THAT THE PRODUCT WAS NOT MANUFACTURED BY CARWILD CORP. NO ROOT CAUSE CAN BE DETERMINATE. THERE IS NOT ENOUGH INFORMATION IN THE TELEFLEX NOTIFICATION SUMMARY, SUCH AS: BODY PLACE OF USE, SOLUTION USED, TIME OF THE SPONGE INSIDE THE PATIENT AND SAMPLES SENT WERE NOT MANUFACTURED BY CARWILD CORP." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTED OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    REPORTED AS "NEURO SPONGES FALLING APART". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    REPORTED AS "NEURO SPONGES FALLING APART". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198102 SPG NEURO STRL XRAY STRG 1X3 200/BX GAUZE/SPONGE, INTERNAL EFQ TELEFLEX MEDICAL 22D1297 04026704417506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown