BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGYLE

    MDR report key: 5169 · Received May 17, 1993

    Report

    Report Number
    5169
    Event Type
    Death
    Date Received
    May 17, 1993
    Date of Event
    April 9, 1993
    Manufacturer
    SHERWOOD MEDICAL PRODUCTS
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PREMATURE INFANT (30 WEEKS GESTATION TRANSFERRED FROM ANOTHER INSTITUTION FOLLOWING TRAUMATIC VAGINAL DELIVERY. UPON ARRIVAL, AN UMBILICAL CATHETER WAS INSERTED AT 9:30 PM. TWO AND ONE HALF HOURS LATER, THE PATIENT EXPIRED. AUTOPSY REVEALED PERFORATED UMBILICAL ARTERY SECONDARY TO CATHETER INSERTION. DETERMINE REPORTABLE: 4/20/93INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, INHERENT RISK OF PROCEDURE, PORT. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. 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 ARGYLE UMBILICAL VESSEL CATHETER FOS SHERWOOD MEDICAL PRODUCTS 3.5 FR.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Death