BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE I.V. CATHETER

    MDR report key: 5422 · Received April 9, 1993

    Report

    Report Number
    5422
    Event Type
    Injury
    Date Received
    April 9, 1993
    Date of Event
    March 4, 1993
    Report Date
    March 9, 1993
    Manufacturer
    MENLO COM
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    LANDMARK 24G INSERTED WITH NO DIFFICULTY DURING INSERTION. GOOD BLOOD RETURN. CATHETER FLUSHED WITH HEPARIN 1.5CC (100 U/CC). SOON AFTER DRESSING PLACED ON CATHETER PATIENT COMPLAINED OF DIZZINESS AND SHORTNESS OF BREATH WITH AUDIBLE WHEEZES. PATIENT HAS KNOWN BRONCHOSPASM SO UPDRAFT PRESCRIPTION WAS STARTED. IMMEDIATELY THEREAFTER PATIENT HAD SEVERE LARYNGOSPASM WITH LITTLE OR NO AIRWAY, SEIZURE ACTIVITY WITH APPARENT RESPIRATORY ARREST. PATIENT WAS AMBU-BAGGED, GIVEN STEROID AND BENADRYL WITH SPONTANEOUS RESPONSE. PATIENT RETURNED TO BASELINE CONDITIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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: INVALID DATA. 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 LANDMARK MIDLINE I.V. CATHETER FOZ MENLO COM 24G 209142

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention