BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEOESOPHAGEAL PUNCTURE SET

    MDR report key: 8611948 · Received May 14, 2019

    Report

    Report Number
    MW5086630
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 10, 2019
    Manufacturer
    INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL LLC
    Product Code
    FSM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) MALE. DURING PROCEDURE A PIECE OF THE PLASTIC SHEATH BROKE OFF INSIDE THE PATIENT. PIECE WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE PATIENT. A SECOND SHEATH WAS ATTEMPTED AND ALSO STARTED TO TEAR, BUT DID NOT BREAK OFF. SECOND SHEATH REMOVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403502 TRACHEOESOPHAGEAL PUNCTURE SET TRAY, SURGICAL KIT FSM INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL LLC 0000099350
    403503 TRACHEOESOPHAGEAL PUNCTURE SET TRAY, SURGICAL KIT FSM INHEALTH TECHNOLOGIES / FREUDENBERG MEDICAL LLC 0000099350

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization