BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 5894 · Received May 10, 1993

    Report

    Report Number
    2925153-1992-00003
    Event Type
    Injury
    Date Received
    May 10, 1993
    Date of Event
    December 10, 1992
    Report Date
    March 5, 1993
    Manufacturer
    UNKNOWN
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CATHETER KNOTTED ON END INSIDE PATIENT. GAVE LIDOCAINE TO REMOVEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERALLY INSERTED CENTRAL CATHETER PICC CATHETER (V-CATH, 3FR) DXG UNKNOWN 014

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention