BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE

    MDR report key: 18457479 · Received January 5, 2024

    Report

    Report Number
    1526012-2023-00017
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    September 28, 2023
    Report Date
    January 5, 2024
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    PIF
    PMA / PMN Number
    K142989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A RESPONSE TO REPORT # (B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 12/07/2023. BASED ON THE PROVIDED INFORMATION, THE INCIDENT IS NOT A REPORTABLE EVENT PER 21 CFR SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. AMT REACHED OUT TO THE REPORTER IN ATTEMPTS TO RETRIEVE THE DEVICE FOR EXAMINATION. THE REPORTER INDICATED THAT THE DEVICE WAS NOT AVAILABLE FOR RETURN. SINCE THE DEVICE WAS NOT RETURNED, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED, AND DEVICE FAILURE COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW FOUND NO DEFECTS AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM THE SAME MANUFACTURED BATCH. BASED ON THE PROVIDED INFORMATION THE REPORTED PROBLEM IS NOT BELIEVED TO HAVE BEEN CAUSED BY A MANUFACTURING DEFECT. COMPLAINT # (B)(4) WAS ASSIGNED TO THIS REPORT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN UF REPORT #: (B)(4), "ENTERNAL EXTENSION SET (FOR G-TUBE) DISCOVERED TO HAVE CRACK AT THE Y-INSERTION SITE. THIS TUBING IS LESS THAN 48 HOURS OLD. ENFIT, PART # 8-1255-ISOSAF LOT # 230824-091."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569129 MINI ONE ENTERAL EXTENSION SET PIF APPLIED MEDICAL TECHNOLOGY, INC. E8-1255-ISOSAF 230824-091

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Male