BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEAL TUBE, CUFFED, NASAL PREFORMED

    MDR report key: 18666257 · Received February 8, 2024

    Report

    Report Number
    8040412-2024-00048
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    November 17, 2023
    Report Date
    January 11, 2024
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER REPORTED: "THERE WAS NO SAMPLE RETURN FOR INVESTIGATION AND LIMITED DETAILS PROVIDED REGARDING THE AFFECTED PRODUCT. FROM THE REPORTED EVENT DESCRIPTION, WRONG PRODUCT RECEIVED BY THE CUSTOMER WAS DUE TO THE INCORRECT DELIVERY AND VERY UNLIKELY DUE TO THE MANUFACTURING PROCESS. THERE WAS NO SAMPLE RETURNED FOR INVESTIGATION TO THIS COMPLAINT. THUS, THIS COMPLAINT CANNOT BE CONFIRMED. "TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: CUSTOMER NOTED BLEEDING IN SEVERAL CASES WHEN USING THE NASAL TUBES. THE NASAL TUBES THAT HE RECEIVED ARE MUCH STIFFER THAN THE USUAL ONES, CAUSING BLEEDING DURING ANESTHESIA OF THE CHILDREN. HE PROVIDED US 3 PATIENT REPORTS WITH BLEEDINGS CAUSED BY THE STIFF TUBES. IN THIS CASE THE PATIENT WAS A DENTAL SURGERY CHILD / DURATION OF ANESTHESIA 01:05 PM - 03:15 PM PATIENT COMPLICATION: ADENOIDS, BLEEDING BLOOD LOSS 20-50MLS, NO INDICATION FOR TRANSFUSION. THE TRAUMA WAS CAUSED BY LOSS OF VISIBILITY OF THE LARYNX. NASAL TAMPONADES USED TO STOP BLEEDING. ASSOCIATED COMPLAINTS 8040412-2024-00019, 8040412-2024-00018 AND 8040412-2024-00028.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: CUSTOMER NOTED BLEEDING IN SEVERAL CASES WHEN USING THE NASAL TUBES. THE NASAL TUBES THAT HE RECEIVED ARE MUCH STIFFER THAN THE USUAL ONES, CAUSING BLEEDING DURING ANESTHESIA OF THE CHILDREN. HE PROVIDED US 3 PATIENT REPORTS WITH BLEEDINGS CAUSED BY THE STIFF TUBES. IN THIS CASE THE PATIENT WAS A DENTAL SURGERY CHILD / DURATION OF ANESTHESIA 01:05 PM - 03:15 PM PATIENT COMPLICATION: ADENOIDS, BLEEDING BLOOD LOSS 20-50MLS, NO INDICATION FOR TRANSFUSION. THE TRAUMA WAS CAUSED BY LOSS OF VISIBILITY OF THE LARYNX. NASAL TAMPONADES USED TO STOP BLEEDING. ASSOCIATED COMPLAINTS 8040412-2024-00019, 8040412-2024-00018 AND 8040412-2024-00028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278523 TRACHEAL TUBE, CUFFED, NASAL PREFORMED TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. IPN041432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown