BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TUBES BLUSELECT

    MDR report key: 13195169 · Received January 7, 2022

    Report

    Report Number
    3012307300-2022-00317
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 21, 2021
    Report Date
    June 9, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTC
    UDI-DI
    15019517076202
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. ONE USED DECONTAMINATED SAMPLE 10009163-002 7MM DEHT BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION WE NOTICED THAT INFLATION LINE WAS DETACHED FROM PILOT BALLOON. SIMILAR CUSTOMER COMPLAINTS HAVE BEEN RECENTLY RECEIVED THEREFORE INTERNAL NON-CONFORMITY REPORT NCR-000928 WAS CREATED WITH PURPOSE TO EVALUATE THIS ISSUE. THE ANALYSIS PERFORMED IN THE SAMPLE RECEIVED CONCLUDED THAT THE OCCURRENCE OF THIS FAILURE CONDITION COULD BE CAUSED BY: NOT ENOUGH THF SOLVENT AT JOINT CAUSE BY BAD CONDITION ON THE THF FEEDER SYSTEM EQUIPMENT. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. ANY RELEVANT DMRS, NCRS, ETS: THERE NO RELEVANT NON-CONFORMANCE (NCR'S) OR ENGINEERING TEST (ET) FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWENTY-EIGHT (28) DAYS AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER NOTICED THE INFLATION LINE WAS DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169601 PORTEX TUBES BLUSELECT BAG, RESERVOIR BTC SMITHS MEDICAL INTERNATIONAL, LTD. 101/870/070CZ 15019517076202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown