BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVOL

    MDR report key: 4255 · Received July 23, 1992

    Report

    Report Number
    4255
    Event Type
    Death
    Date Received
    July 23, 1992
    Date of Event
    February 20, 1992
    Report Date
    March 4, 1992
    Manufacturer
    BARD
    Product Code
    GBN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    2 1/2 MONTHS OLD MALE WITH PRIOR HISTORY OF 3 OPERATIONS FOR NECROTIZING ENTROCOLITIS & EVISCERATION. EXPLORATORY SURGERY PERFORMED IN HOPE OF EXCISING THE BOWEL & COVERING WITH MERCILENU MESH OR CAVER SKIN. DURING SURGERY, FAIRLY LARGE AMOUNT OF BLOOD LOSS WERE NOTED & TRANSFUSION CONTINUED. DURING THE DISECTION OF THE MESENTERY, IT WAS OBSERVED THAT HARDLY ANY BLOOD FLOW AT THE DISECTION. SURGEON THE DISECTION. SURGEON PROCEED TO CLOSE. PATIENT WENT INTO CARDIAC ARREST. RESUSITATION CONTINUED FOR 20-25 MINUTES. PATIENT WAS PRONOUNCED DEAD. AS PATIENT WAS UNDRAPE CATHETER WAS FOUND TO HAVE A HOLE AT APPROXIMATELY AT THE HUB. THERE WERE CLEAR SIGN OF LEAK AGE & TOWELS UNDER THE PATIENT WERE SOAKED WITH BLOOD. CATHETER WAS INSERTED PRIOR TO SURGERY BY STAFF PHYSICIAN 24 DAYS AGO IN NICU. THE CATHETER WAS IMPOUNDED FOR INVESTIGATION. ECRI WAS CONSULTED VIA TELEPHONE BY RISK MANAGEMENT. UPON CLOSER VISUAL INSPECTION OF THE CATHETER BY HOSPITAL BIOMEDICAL ENGINEERING MANAGER AND RISK MANAGMENT DIRECTOR ON 3/3/92, IT WAS OBSERVED THAT THE HOLE IN QUESTION DID NOT SEEM LIKE A RUPTURE OF THE CATHETER. IT WAS FURTHER OBSERVED THAT THE BREAKAGE IN THE CATHETER SEEMS MORE OF A WEDGE SHAPE WHICH LOOKED MORE LIKE "," IN SHAPE. IT IS UNCLEAR AT THIS TIME AS TO THE CAUSE OF BREAKAGE IN THE CATHETER THAT CONTRIBUTED TO THIS EVENTDEVICE LABELED FOR SINGLE USE. 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL Implant 2.7 F PEDS SINGLE LUMEN VASCULAR CATHETER GBN BARD 60004-2 36DB4658

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death