BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCEN770B30 BLUNT TIP

    MDR report key: 19621199 · Received June 26, 2024

    Report

    Report Number
    3003249645-2024-00028
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Report Date
    August 21, 2024
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS SUBSEQUENTLY REPORTED THAT THE NUMBER OF USES FOR THIS INSTRUMENT IS UNKNOWN AND COULD NOT BE ESTIMATED. IT IS NOTED THAT THE INSTRUMENT WAS MANUFACTURED SIX (6) YEARS AGO.

    Additional Manufacturer Narrative · 0

    THE BLUNT TIP SUCTION TUBE (MCEN770B30) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. EVALUATION FOUND THAT THE STEM OF THE SUCTION TUBE WAS BROKEN AT THE BASE OF THE HANDLE AT THE WELD. IT WAS DETERMINED THAT THE ERROR IN THE HANDLING OF THE INSTRUMENT BY THE CUSTOMER; AN EXCESSIVE FORCE WAS APPLIED LEADING TO STEM BREAKAGE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THIS REPORT IS 2 OF 10 AND IS RELATED TO MFG REPORT NUMBERS: 3003249645-2024-00029, 3003249645-2024-00031, 3003249645-2024-00030, 3003249645-2024-00032, 3003249645-2024-00033, 3003249645-2024-00034, 3003249645-2024-00035, 3003249645-2024-00036, 3003249645-2024-00037. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE WELDING BETWEEN THE HANDLE AND THE STEM OF THE BLUNT TIP SUCTION TUBE (MCEN770B30) BROKE DURING SURGERY. THE SURGEON HAD TO USE ANOTHER PRODUCT. THIS REPORTEDLY LED TO A LOSS OF TIME. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751488 SUCTION TUBE MCEN770B30 BLUNT TIP PFM11 JZF INTEGRA MICROFRANCE S.A.S. 2484147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown