BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE ENTERAL EXTENSION SET (ENFIT)

    MDR report key: 12586452 · Received October 6, 2021

    Report

    Report Number
    1526012-2021-00018
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    August 18, 2021
    Report Date
    October 6, 2021
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    PIF
    UDI-DI
    00842071116095
    PMA / PMN Number
    K142989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 09/07/2021. BASED ON THE PROVIDED INFORMATION, THE COMPLAINT 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 HAS MADE SEVERAL CONTACT REQUESTS TO THE REPORTER TO OBTAIN ADDITIONAL INFORMATION AND THE DEVICE FOR EXAMINATION, BUT WE HAVE RECEIVED NO RESPONSE FROM THE ORIGINAL REPORTER AT THIS TIME. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED AT THE TIME OF THIS REPORT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT NUMBER PROVIDED, WITH NO ANOMALIES FOUND AND NO SIMILAR COMPLAINTS REPORTED FROM THE SAME BATCH. THE EXACT CAUSE FOR THE REPORTED CRACKING/LEAKAGE IS UNKNOWN AT THIS TIME. BASED ON THE PROVIDED INFORMATION AND THE DEVICE HISTORY REVIEW COMPLETED, THE REPORTED ISSUE IS NOT BELIEVED TO HAVE BEEN CAUSED BY A MANUFACTURING DEFECT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE(S) OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ANY ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    PER THE ORIGINAL REPORTER'S DESCRIBED EVENT OR PROBLEM FROM REPORT #: (B)(4), THE FOLLOWING WAS REPORTED: "PROBLEM 1: THE NURSES REPORTED THAT THE NEW ENFIT AMT MINI ONE ENTERAL EXTENSION SETS LEAK OUT THE MEDICATION PORT WHEN THE TUBE FEEDINGS ARE INFUSING. THE NURSES REPORTED THAT THE CAP DOES NOT FIT SECURELY AND WHEN THE CONTINUOUS FEEDINGS ARE INFUSING THE MEDICATION PORT CAP POPS OFF. PROBLEM 2: THE OUTSIDE WHITE PORTS CRACK OFTEN REQUIRING TUBING CHANGES. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: PROVIDE TUBING FOR CONTINUOUS ENTERAL FEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485140 AMT MINI ONE ENTERAL EXTENSION SET (ENFIT) GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF APPLIED MEDICAL TECHNOLOGY, INC. 8-1255-ISOSAF 210603-440 00842071116095

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR