BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHEATH INTRODUCER KIT 6.0 FR.

    MDR report key: 4899 · Received August 5, 1992

    Report

    Report Number
    4899
    Event Type
    Injury
    Date Received
    August 5, 1992
    Date of Event
    April 1, 1992
    Report Date
    August 5, 1992
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    EYT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    INTRODUCER 6.0 FR. HAD A CRACK AT INSERTION HUBINVALID 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. INVALID DATA - WHETHER 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 SHEATH INTRODUCER KIT 6.0 FR. EYT ARROW INTERNATIONAL AK-6-054-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention