BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREFLOW MICROLINE CENTRAL VENOUS CATHETER FOR NEONATES

    MDR report key: 4236 · Received June 30, 1992

    Report

    Report Number
    4236
    Event Type
    Injury
    Date Received
    June 30, 1992
    Date of Event
    February 4, 1992
    Report Date
    June 30, 1992
    Manufacturer
    BECTON DICKINSON CRITICAL CARE MONITORING
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TUBING BROKE AFTER BEING INSERTED; REMOVED VIA A MINOR SURGICAL PROCEDUREINVALID 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: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFLOW MICROLINE CENTRAL VENOUS CATHETER FOR NEONATES DXG BECTON DICKINSON CRITICAL CARE MONITORING M9NX003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention