BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCO770L30 HOLES TIP

    MDR report key: 19641146 · Received June 30, 2024

    Report

    Report Number
    3003249645-2024-00038
    Event Type
    Malfunction
    Date Received
    June 30, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOLES TIP SUCTION TUBE (MCO770L30) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION FOUND THAT THE STEM OF THE SUCTION TUBE WAS BROKEN AT THE BASE OF THE HANDLE AT THE WELD. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT AN ERROR IN THE HANDLING OF THE INSTRUMENT BY THE CUSTOMER, AN EXCESSIVE FORCE WAS APPLIED LEADING TO STEM BREAKAGE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE NUMBER OF USES FOR THE INSTRUMENT IS UNKNOWN AND CANNOT BE ESTIMATED. IT IS NOTED THAT THE DEVICE WAS MANUFACTURED ONE YEAR AGO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE WELDING BETWEEN THE HANDLE AND THE STEM OF THE HOLES TIP SUCTION TUBE (MCO770L30) BROKE. THE SURGEON HAD TO USE ANOTHER PRODUCT. THIS LED TO A LOSS A TIME; HOWEVER, THE DELAY WAS INFERIOR TO 30 MINUTES. IT WAS REPORTED THAT THERE WAS NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184854 SUCTION TUBE MCO770L30 HOLES TIP PFM11 JZF INTEGRA MICROFRANCE S.A.S. 7005252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown