BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/L PERC 8FR 65D

    MDR report key: 8822398 · Received July 24, 2019

    Report

    Report Number
    3006260740-2019-02167
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OF THE 3 DEVICES, 2 LOT NUMBERS WERE PROVIDED, AND LOT HISTORY REVIEWS WERE PERFORMED. OF THE 3 REPORTED MALFUNCTIONS, DEFECTIVE COMPONENT WERE CONFIRMED FOR 2 DEVICES. 1 SAMPLE WAS SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. OF THE 3 DEVICES, THE PRODUCT CATALOG NUMBER OF 1 DEVICE WAS UPDATED TO UNKNOWN. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711800. CENTRAL VENOUS CATHETER ALLEGEDLY HAD DEFECTIVE COMPONENTS. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL THREE EVENTS HAD NO REPORTED PATIENT INJURY. THE MALFUNCTIONS INVOLVED PATIENTS WITHOUT CONSEQUENCE. THREE PATIENTS AGE RANGED FROM 17-44 YEARS, FEMALES, AND WEIGHT RANGED FROM 37-102 KGS.

    Additional Manufacturer Narrative · 1

    ONE OF THE DEVICES HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICES FOR THE OTHER TWO MALFUNCTIONS WERE NOT RETURNED; THEREFORE, THEY ARE INCONCLUSIVE FOR HAVING A DEFECTIVE COMPONENT. HE INVESTIGATION FOR THE MALFUNCTION WITH THE RETURNED DEVICE IS CURRENTLY UNDERWAY. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 7711800 CENTRAL VENOUS CATHETER ALLEGEDLY HAD DEFECTIVE COMPONENTS. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED PATIENTS WITHOUT CONSEQUENCE. TWO MALFUNCTIONS INVOLVED A PATIENT THAT WAS A (B)(6) YEAR OLD FEMALE WEIGHING (B)(6) KGS. THE THIRD MALFUNCTION INVOLVED A (B)(6) YEAR OLD FEMALE WEIGHING (B)(6) KGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617386 S/L PERC 8FR 65D CENTRAL VENOUS CATHETER LJS BARD ACCESS SYSTEMS 7711800 REDN2519, UNKNOWN 00801741036743

    Patients

    Seq Age Sex Outcome Treatment
    1