BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE MCEN770B30 BLUNT TIP

    MDR report key: 19621202 · Received June 26, 2024

    Report

    Report Number
    3003249645-2024-00030
    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
    OTHER
    Health Professional
    N

    Narratives

    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. 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 THERE WAS AN ERROR IN THE HANDLING OF THE INSTRUMENT BY THE CUSTOMER. AN EXCESSIVE FORCE WAS APPLIED LEADING TO STEM BREAKAGE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, H3, H11. IT WAS SUBSEQUENTLY REPORTED THAT THE NUMBER OF USES FOR THIS INSTRUMENT IS UNKNOWN AND CANNOT BE ESTIMATED.

    Description of Event or Problem · 0

    THIS REPORT IS 4 OF 10 AND IS RELATED TO MFG REPORT NUMBERS: 3003249645-2024-00029, 3003249645-2024-00028, 3003249645-2024-00031, 3003249645-2024-00032, 3003249645-2024-00033, 3003249645-2024-00034, 3003249645-2024-00035, 3003249645-2024-00036, 3003249645-2024-00037. IT WAS REPORTED THAT THE WELDING OF THE BLUNT TIP SUCTION TUBE (MCEN770B30) BROKE BETWEEN THE HANDLE AND STEM. ANOTHER DEVICE WAS AVAILABLE FOR USE. NO INFORMATION ON PATIENT IMPACT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751491 SUCTION TUBE MCEN770B30 BLUNT TIP PFM11 JZF INTEGRA MICROFRANCE S.A.S. 3491183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown