BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL TUBE, CUFFED, NASAL PREFORMED

    MDR report key: 18613813 · Received January 31, 2024

    Report

    Report Number
    8040412-2024-00030
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 5, 2024
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER REPORTED: "NO SAMPLE WAS RETURNED FOR INVESTIGATION. HOWEVER, BY REVIEWING PICTURE FROM SAP, THE PRODUCT WAS PACK WITH CORRECT LABELLING BY REVIEWING THE PICTURE SIDE BY SIDE. 100% VISUAL INSPECTION WAS CONDUCTED DURING PACKING PROCESS SUCH DEFECT ABLE TO DETECT UPON INSPECTION. REVIEWING THE LOT REJECTION RATE (LRR) DATA FOR THIS AFFECTED LOT ALSO FOUND ZERO FAILURE WHICH MEANS THIS LOT WAS RELEASED WITHOUT ANY QUALITY ISSUE. 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. WITH LIMITED INFORMATION PROVIDED, NO FURTHER INVESTIGATION COULD BE CONDUCTED. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE PHYSICIAN NOTED THAT THE INCORRECT DEVICES WERE RECEIVED. HE ALWAYS AND ONLY ORDERED AND RECEIVED PN 111782 (SEVERAL SIZES) SAFETY SILK NASAL TUBES - CONFIRMED BY SAP - BUT HE RECEIVED PN 111781 (SIZE 4 / 4,5 / 5). THESE 111781 NASAL TUBES ARE MUCH STIFFER THAN THE ORDERED 111782. THE INCORRECT DELIVERY WASN'T NOTED BY THE TRAINEE WHO DID THE INCOMING BOOKING OF THE DEVICES. ASSOCIATED COMPLAINTS 8040412-2024-00030, 8040412-2024-00031, 8040412-2024-00032, 8040412-2024-00033, 8040412-2024-00034, 8040412-2024-00035 AND 8040412-2024-00036.

    Description of Event or Problem · 0

    THE PHYSICIAN NOTED THAT THE INCORRECT DEVICES WERE RECEIVED. HE ALWAYS AND ONLY ORDERED AND RECEIVED PN 111782 (SEVERAL SIZES) SAFETY SILK NASAL TUBES - CONFIRMED BY SAP - BUT HE RECEIVED PN 111781 (SIZE 4 / 4,5 / 5). THESE 111781 NASAL TUBES ARE MUCH STIFFER THAN THE ORDERED (B)(4). THE INCORRECT DELIVERY WASN'T NOTED BY THE TRAINEE WHO DID THE INCOMING BOOKING OF THE DEVICES. ASSOCIATED COMPLAINTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245770 TRACHEAL TUBE, CUFFED, NASAL PREFORMED TUBE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. KME21M1780

    Patients

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