BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFETY CLR MURPHY CUF ET

    MDR report key: 23013253 · Received September 10, 2025

    Report

    Report Number
    8040412-2025-00225
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    PMA / PMN Number
    K961837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). ONE (1) ACTUAL SAMPLE WAS RECEIVED FOR INVESTIGATION. THE BATCH NUMBER COULD NOT BE VERIFIED AS THE SAMPLE WAS RECEIVED WITHOUT ITS PACKAGING. BASED ON VISUAL INSPECTION, A RUPTURED HOLE WAS OB-SERVED ON THE CUFF. FURTHER INSPECTION USING THE KEYENCE DIGITAL MICROSCOPE CONFIRMED THAT THE HOLE ON THE CUFF EXHIBITED A CLEAR RUPTURE, WITH TORN AND JAGGED EDGES INDICATIVE OF A BURST FAILURE. THE BAL-LOON MATERIAL HAD LOST ITS ORIGINAL SHAPE AND STRUCTURAL INTEGRITY. THE THIN, TRANSPARENT MATERIAL AP-PEARED CRUMPLED AND FOLDED AROUND THE RUPTURE SITE, SUGGESTING THAT THE BURST OCCURRED UNDER PRES-SURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON VISUAL INSPECTION, IT WAS CONFIRMED THAT THE HOLE ON THE CUFF EXHIBITED A CLEAR RUPTURE, WITH TORN AND JAGGED EDGES INDICATIVE OF A BURST FAILURE. THE THIN, TRANSPARENT MATERIAL APPEARED CRUMPLED AND FOLDED AROUND THE RUPTURE SITE, SUGGESTING THAT THE BURST OCCURRED UNDER PRESSURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE RELATED TO COMPLAINT WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. HOWEVER, THE ROOT CAUSE OF THE DEFECT REMAINS UNDETER-MINED. THEREFORE, CORRECTIVE ACTION IS NOT REQUIRED AS PART OF THIS COMPLAINT INVESTIGATION AS THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "INFLATION CUFF RUPTURED INSIDE PATIENT'S THROAT. LATERAL RAD DONE TO CHECK DAMAGE AND IT WAS CONCLUDED THE PATIENT HAS ESOPHAGEAL TEAR. THE PATIENT WAS PRONE TO BE INTUBATED AND THEN PLACED IN LATERAL. THE PATIENT WAS HERE FOR DENTAL CLEANING WITH EXTRACTIONS. THE PRESSURE WAS ESTIMATED BUT CUFF WAS TESTED PRIOR TO BEING PLACED IN THE PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "INFLATION CUFF RUPTURED INSIDE PATIENT'S THROAT. LATERAL RAD DONE TO CHECK DAMAGE AND IT WAS CONCLUDED THE PATIENT HAS ESOPHAGEAL TEAR. THE PATIENT WAS PRONE TO BE INTUBATED AND THEN PLACED IN LATERAL. THE PATIENT WAS HERE FOR DENTAL CLEANING WITH EXTRACTIONS. THE PRESSURE WAS ESTIMATED BUT CUFF WAS TESTED PRIOR TO BEING PLACED IN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506676 SAFETY CLR MURPHY CUF ET TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. 40E25A5158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.