BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEPATH HEMODIALYSIS CATHETER

    MDR report key: 12178897 · Received July 16, 2021

    Report

    Report Number
    3006260740-2021-02760
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 21, 2021
    Report Date
    June 25, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MSD
    UDI-DI
    00801741012174
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 06/2022).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT, THE AIRGUARD VALVE ALLEGEDLY HAD A BLOOD LEAK AT THE PROXIMAL END. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDE USED THE THUMB TO STOP THE BLOOD LEAK. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078720 GLIDEPATH HEMODIALYSIS CATHETER DIALYSIS CATHETER MSD C.R. BARD, INC. (BASD) -3006260740 5393190 REEW1751 00801741012174

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other