BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL SEAL CHEST DRAINAGE UNIT

    MDR report key: 137736 · Received December 12, 1997

    Report

    Report Number
    9611018-1997-00017
    Event Type
    Malfunction
    Date Received
    December 12, 1997
    Report Date
    November 13, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, ONE INCIDENT HAS OCCURRED DUE TO THE FACT THAT THE CONNECTOR TUBING FROM THE PT TO THE SENTINEL SEAL HAS BEEN PUSHED TOO FAR DOWN INTO THE COLLECTION CHAMBER. WHEN THE COLLECTION CHAMBER WAS FULL OF BLOOD, THE BLOOD BLOCKED THE EXIT OF THE CONNECTING TUBE AND THERE WAS NO SUCTION TO THE PT. NO INJURY WAS REPORTED AS THE PT WAS BEING MONITORED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINEL SEAL CHEST DRAINAGE UNIT CHEST DRAINAGE UNIT KDQ SHERWOOD MEDICAL INDUSTRIES NA 97I236T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN