BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE

    MDR report key: 11890598 · Received May 26, 2021

    Report

    Report Number
    1526012-2021-00014
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    March 28, 2021
    Report Date
    May 26, 2021
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071109028
    PMA / PMN Number
    K142989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO MEDWATCH REPORT # MW5100424 WHICH WAS RECEIVED BY AMT FROM THE FDA ON 04/27/2021. 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. THE REPORTED INDICATED THAT THE PATIENT WAS NOT HARMED. AMT IS HAS REACHED OUT TO THE REPORTER IN AN ATTEMPTS TO OBTAIN THE DEVICE FOR EXAMINATION. THE DEVICE HAS NOT RETURNED AT THIS TIME, THEREFORE A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE DONE. HOWEVER, A DEVICE HISTORY REVIEW WAS PERFORMED AS THE LOT NUMBER WAS PROVIDED, WITH NO ANOMALIES FOUND. WE WILL CONTINUE TO WORK WITH THE REPORTER IN ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS REPORT AND THE DEVICE FOR EXAMINATION. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT. AMT HAS ASSIGNED COMPLAINT #: (B)(4)TO TRACK THIS RECORD.

    Description of Event or Problem · 1

    THIS REPORT IS IN RESPONSE TO INITIAL REPORT #MW5100424, WHICH PROVIDED THAT THE MINI ONE 24" RIGHT ANGLE FEEDING SET WITH Y-PORT Y PORT SEPARATED FROM TUBING WHEN DISCONNECTING SYRINGE FROM Y PORT. NO OBVIOUS CUTS OR DAMAGE SEEN TO NAKED EYE. PATIENT NOT HARMED. GASTRIC CONTENTS EMPTIED INTO BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787495 MINI ONE ENTERAL EXTENSION SET KNT APPLIED MEDICAL TECHNOLOGY, INC. 8-2455 201123-081 00842071109028

    Patients

    Seq Age Sex Outcome Treatment
    1