BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JACKSON PRATT

    MDR report key: 181903 · Received August 10, 1998

    Report

    Report Number
    MW1014363
    Event Type
    Injury
    Date Received
    August 10, 1998
    Date of Event
    July 22, 1998
    Report Date
    July 31, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    JACKSON PRATT RESERVOIR DID NOT FUNCTION PROPERLY - DID NOT DRAIN FOR PT WHO WAS STATUS POST RIGHT TOTAL MASTECTOMY FOR CARCINOMA OF RIGHT BREAST. NO DRAINAGE OBTAINED VIA JACKSON PRATT FROM 1700 7/22 - 0715 7/23; JACKSON PRATT NOTED BY RN TO BE "AT FULL SUCTION", JACKSON PRATT CHANGED ONCE AND AGAIN DID NOT DRAIN. PT HAD TO BE TAKEN OFF JACKSON PRATT AND HOOKED TO WALL SUCTION, AT WHICH TIME 200CC OF FLUID WAS EVACUATED. PT WAS DISCHARGED WITH A SUCTION RESERVOIR MFG BY ANOTHER CO - NO PROBLEMS NOTED WITH OTHER SUCTION RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON PRATT 100CC SUCTION RESERVOIR WITH ANTI REFLUX VALVE GCY ALLEGIANCE HEALTHCARE CORP * 1961735 OR 1940036

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention