BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOCATH (22GA 1")

    MDR report key: 687 · Received June 9, 1992

    Report

    Report Number
    687
    Event Type
    Malfunction
    Date Received
    June 9, 1992
    Date of Event
    May 12, 1992
    Report Date
    May 22, 1992
    Manufacturer
    BECTON/DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD IV HEPLOCKED FOR ANTIBIOTICS ORDERED. ORDER TO DISCONNECT IV, AS PATIENT WAS DISCHARGED. WHEN IV WAS DISCONNECTED, THE ANGIOCATH WAS MISSING. THE PHYSICIAN WAS NOTIFIED AND THE AREA WAS X-RAYED. AREA EXPLORED IN OR ON MAY 16, 1992 (L CEPHOLIC VIEN) WITH NO FOREIGN BODY FOUND. ON MAY 15, 1992 AN ANGIOGRAM UNDER FLUORO WAS DONE, WITH NO FOREIGN BODY FOUNDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOCATH (22GA 1") Implant IV CATHETER FOZ BECTON/DICKINSON 3828621

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other