BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEPATH

    MDR report key: 14306531 · Received May 6, 2022

    Report

    Report Number
    3006260740-2022-01620
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 23, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MSD
    UDI-DI
    00801741012181
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRATION DATE: 06/2023).

    Additional Manufacturer Narrative · 0

    H10: THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO REPORT THAT MFR RPT# 3006260740-2022-01620 WAS A DUPLICATE RECORD AND WAS OPENED IN ERROR. THE EVENT DETAILS ARE BEING CAPTURED UNDER COMPLAINT FILE # 4951347 AND WAS REPORTED TO THE FDA UNDER MFR RPT# 3006260740-2022-01551. H10: D4 (EXPIRY DATE: 06/2023), G3 H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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 : DEVICE PENDING RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, THE RED CLAMP WAS ALLEGEDLY BROKEN WHEN TRYING TO CLAMP THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, THE RED CLAMP WAS ALLEGEDLY BROKEN WHEN TRYING TO CLAMP THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078663 GLIDEPATH DIALYSIS CATHETER MSD C.R. BARD, INC. (BASD) -3006260740 5393230 REFV4155 00801741012181

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male