BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PICC

    MDR report key: 15418022 · Received September 14, 2022

    Report

    Report Number
    3006260740-2022-03588
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 3, 2022
    Report Date
    September 1, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT USED A PICC CATHETER ON (B)(6) 2022 DUE TO "MALIGNANT PELVIC EFFUSION", AND THE SYMPTOMS OF REDNESS AND SWELLING AT THE SITE OF THE PICC CATHETER APPEARED, AND THE PATIENT HAD NO DISCOMFORT. TREATMENT SITUATION: TREATED WITH TRADITIONAL CHINESE MEDICINE, AND EXTERNALLY APPLIED NIHUANG SAN TO THE PICC, WHICH HAS BEEN TREATED WITH DRUGS. SPECIFIC DRUG DESCRIPTION: CHINESE MEDICINE PACKAGE TREATMENT, EXTERNAL APPLICATION OF NIHUANG SAN TO THE PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622463 BARD PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention