BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE® ENTERAL EXTENSION SET

    MDR report key: 9087980 · Received September 19, 2019

    Report

    Report Number
    1526012-2019-00004
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Report Date
    September 16, 2019
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    PIF
    PMA / PMN Number
    K142989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO MEDWATCH REPORT # MW5088647 WHICH WAS RECEIVED BY AMT FROM THE FDA ON 08/20/2019. 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 DEVICE WAS NOT RETURNED THEREFORE A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE DONE HOWEVER, A DEVICE HISTORY REVIEW WAS PERFORMED AS THE LOT NUMBER WAS PROVIDED. THE EXACT CAUSE FOR THE CRACK IN THE PORT IS UNKNOWN AT THIS TIME. BASED ON THE PROVIDED INFORMATION AND THE DEVICE HISTORY REVIEW COMPLETED IT IS NOT BELIEVED TO HAVE BEEN CAUSED BY A MANUFACTURING DEFECT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    APPLIED MEDICAL TECHNOLOGY RECEIVED VOLUNTARY EVENT REPORT #MW5088647 FROM THE FDA MEDWATCH PROGRAM. THE REPORT STATES THAT THE PATIENT'S G-TUBE EXTENSION CRACKED AT THE MED PORT AND THAT THIS WAS THE SECOND OF THREE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879414 AMT MINI ONE® ENTERAL EXTENSION SET ENTERAL EXTENSION SET PIF APPLIED MEDICAL TECHNOLOGY, INC. 8-2455-ISOSAF 190218-278

    Patients

    Seq Age Sex Outcome Treatment
    1