BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE® ENTERAL EXTENSION SET

    MDR report key: 9087973 · Received September 19, 2019

    Report

    Report Number
    1526012-2019-00002
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    July 9, 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 # (B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 08/26/2019. 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. COMPLAINT # (B)(4) WAS ASSIGNED TO THIS REPORT. ANALYSIS OF THE RETURNED DEVICE CONSISTED OF A VISUAL AND FUNCTIONAL EVALUATION, AS WELL AS A DEVICE HISTORY REVIEW. EXAMINATION OF THE DEVICE DETERMINED THAT A SMALL TEAR HAD OCCURRED THROUGH THE STRAP PLUG OF THE MED-PORT. THIS ALLOWED FOR THE PORT TO EASILY POP OPEN AND/OR LEAK WHEN PRESSURIZED DURING USE. THE EXACT CAUSE FOR THE TEAR IN THE PLUG IS UNKNOWN AT THIS TIME. WE HAVE ATTEMPTED TO REPLICATE THE TEAR IN THE LAB USING SEVERAL METHODS, BUT HAVE BEEN UNSUCCESSFUL IN REPLICATING THE TEAR VISUALIZED IN THE RETURNED PRODUCT. BASED ON THE PROVIDED INFORMATION AND THE EVALUATION 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 #(B)(4) FROM THE FDA MEDWATCH PROGRAM. THE REPORT STATES THAT THERE WERE TWO CRACKS ON THE GT EXTENSION; ONE ON THE MED PORT AND ONE ON THE FEEDING PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879409 AMT MINI ONE® ENTERAL EXTENSION SET ENTERAL EXTENSION SET PIF APPLIED MEDICAL TECHNOLOGY, INC. 8-2455-ISOSAF 190604-016

    Patients

    Seq Age Sex Outcome Treatment
    1