BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)

    MDR report key: 10347960 · Received July 30, 2020

    Report

    Report Number
    3006260740-2020-02709
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741035272
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDN0196 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER CONSULTATION BY DOCTORS FROM HEMATOTHERAPEUTIC DEPARTMENT AND OBTAINING INFORMED CONSENT FROM THIS PATIENT¿S FAMILY, THIS PATIENT UNDERWENT PICC PLACEMENT THROUGH THE RIGHT BRACHIAL VEIN UNDER ULTRASOUND GUIDANCE ON (B)(6) 2020. 35 CM OF THE CATHETER WAS PLACED INTERNALLY, WITH ANOTHER 3CM EXPOSED EXTERNALLY. WHEN MAINTAINING THE CATHETER ON (B)(6) 2020, A NURSE FOUND EXUDATE ON WITH CATHETER. PULLING EXTERNALLY BY 2 CM AND FOUND A CREVASSE. THEN, REMOVED THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807185 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDN0196 00801741035272

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR