BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE)

    MDR report key: 10456649 · Received August 26, 2020

    Report

    Report Number
    3006260740-2020-03037
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741139079
    PMA / PMN Number
    K072230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REDU1385 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT HOSPITALIZED IN CARDIOLOGY THEN CTCV FROM (B)(6) TO (B)(6) FOR INFECTIOUS ENDOCARDITIS. IT WAS REPORTED PICC LINE INSTALLATION ON (B)(6) 2020 (RIGHT ARM)FOR PROLONGED PARENTERAL ANTIBIOTIC THERAPY IN THIS SETTING (- IMAGES ON THE PACS). REVIEWED IN HDJ INFECTIOLOGY ON (B)(6) 2020. OBSERVATION OF SENSORY DISTURBANCES (PAINFUL PARESTHESIAS) IN RIGHTULNAR TERRITORY WITH MOTOR DEFICIT (INTEROSSEOUS IMPAIRMENT) WITHOUT SENSORY DEFICIT. PATIENT REPORTS THE APPEARANCE OF THIS PAINFUL SYMPTOMATOLOGY DURING HOSPITALIZATION, NOT BEING ABLE TO DATE IT EXACTLY. EMG DR ON (B)(6): CONFIRMATION OF ULNAR NERVE DAMAGE IN THE RIGHT ARM, WITHOUT EVIDENCE FOR AN UNDERLYING NEUROPATHY. -> SUSPICION OF ULNAR LESION ON PICCLINE PLACEMENTMOTOR DEFICIT ABDUCTOR MUSCLES OF THE V AND INTEROSSEOUS + PAINFUL PARESTHESIAS IN ULNAR TERRITORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920479 POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDU1385 00801741139079

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention