BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRO, 4F SL, 60CM, W/3CG BEDSIDE

    MDR report key: 10777182 · Received November 3, 2020

    Report

    Report Number
    3006260740-2020-20355
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 25, 2020
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE INITIAL COMPLAINT APPEARED TO BE A REPORTABLE OCCURRENCE. UPON RECEIVING ADDITIONAL INFORMATION, IT WAS DETERMINED THAT A REPORTABLE EVENT HAD NOT OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, INCORRECT ITEM WAS ALLEGEDLY FOUND IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING AND A PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, INCORRECT ITEM WAS ALLEGEDLY FOUND IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245678 GRO, 4F SL, 60CM, W/3CG BEDSIDE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other