BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR

    MDR report key: 5131415 · Received October 7, 2015

    Report

    Report Number
    3003898360-2015-00708
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 28, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE SHER-I-BRONCH ENDOBRONCHIAL TUBE, FOUR SUCTION CATHETERS, AND ONE DOUBLE SWIVEL ACCESSORY PACK. THE ENDOBRONCHIAL TUBE AND THE SUCTION CATHETERS WERE ALL RETURNED SEALED IN THEIR ORIGINAL PACKAGING. THE DOUBLE SWIVEL ACCESSORY PACK WAS RECEIVED ASSEMBLED WITHOUT PACKAGING. VISUAL EXAMINATION OF THE RETURNED COMPONENTS REVEALED THAT ALL PARTS APPEARED TYPICAL WITH NO OBSERVED DEFECTS OR ANOMALIES. THE Y-CONNECTOR ON THE DOUBLE SWIVEL APPEARED TYPICAL. NO DEFECTS WERE OBSERVED. HOWEVER, A CRACK WAS FOUND ON THE FEMALE SWIVEL CONNECTION PORT. THE RETURNED COMPONENTS WERE FUNCTIONALLY TESTED BY CHECKING THE CONNECTION OF THE DOUBLE SWIVEL 15MM CONNECTORS INTO THE Y-CONNECTOR. THE PARTS ARE FIT SECURELY WITH NO DEFECTS OBSERVED. THE REPORTED COMPLAINT OF A BROKEN Y-CONNECTOR COULD NOT BE CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE Y-CONNECTOR THAT WAS RETURNED HAD NO DEFECTS. HOWEVER, A CRACK WAS FOUND ON THE FEMALE SWIVEL CONNECTION PORT. THEREFORE, THE POTENTIAL ROOT CAUSE FOR THIS COMPLAINT ISSUE IS MANUFACTURING RELATED. A CAPA HAS BEEN INITIATED TO INVESTIGATE THIS COMPLAINT ISSUE AND RELATED DEFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: A CONCLUSION CODE COULD NOT BE CHOSEN. THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNKNOWN. THE FAILURE MODE "Y CONNECTOR BROKEN PRIOR" WAS CONFIRMED WITH THE PICTURE ATTACHED. NO OTHER DEFECTS WERE OBSERVED. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES REQUIRED. FAILURE MODE "Y CONNECTOR BROKEN PRIOR" COULD BE CONFIRMED WITH PICTURE ATTACHED. CAPA (B)(4) WAS OPEN IN ORDER TO INVESTIGATE AND ADDRESS CORRECTIVE ACTIONS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE "Y" CONNECTOR OF THE DEVICE WAS BROKEN. THE ALLEGED ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE "Y" CONNECTOR OF THE DEVICE WAS BROKEN. THE ALLEGED ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664831 HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR TRACHEAL/BRONCHIAL TUBE BTR TELEFLEX MEDICAL 01A1200217

    Patients

    Seq Age Sex Outcome Treatment
    1