BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERIDAN

    MDR report key: 347690 · Received August 15, 2001

    Report

    Report Number
    347690
    Event Type
    Injury
    Date Received
    August 15, 2001
    Date of Event
    July 4, 2001
    Report Date
    July 5, 2001
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE SEPARATED FROM HUB DURING INTUBATION DONE AT BIRTH FOR SUCTIONING OF MECONIUM. TUBE LODGED IN INFANT'S ESOPHAGUS. REQUIRED ADMISSION TO SPECIAL CARE NURSERY & EAR, NOSE & THROAT CONSULT. EAR, NOSE & THROAT DR REMOVED TUBE WITH FORCEPS UNDER DIRECT OBSERVATION WITH LARYNGOSCOPE. INFANT GIVEN CONSCIOUS SEDATION DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37301 SHERIDAN UNCUFFED TRACHEAL TUBE 3.5 BTR SHERIDAN CATHETER CORP. * 115984

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| R NEOTECH MECONIUM ASPIRATOR.