BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL TUBE, CUFFED, NASAL PREFORMED

    MDR report key: 18613927 · Received January 31, 2024

    Report

    Report Number
    8040412-2024-00033
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE WAS NO ACTUAL SAMPLE OR REPRESENTATIVE SAMPLE RETURNED FOR THIS INVESTIGATION AND NO PHOTO RECEIVED FOR REFERENCE. REVIEW FROM LRR DATA THERE IS ZERO LRR FAILURE REPORTED FOR THIS LOT KME23B3286. WITH LIMITED INFORMATION PROVIDED, NO FURTHER INVESTIGATION COULD BE CONDUCTED. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    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 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, 8040412-2024-00034, 8040412- 2024-00035 AND 8040412-2024-00036.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392181 TRACHEAL TUBE, CUFFED, NASAL PREFORMED BE, TRACHEAL (W/WO CONNECTOR BTR TELEFLEX MEDICAL SDN. BHD. KME23C0132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.