BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE(R)

    MDR report key: 10673041 · Received October 13, 2020

    Report

    Report Number
    1526012-2020-00015
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    August 1, 2020
    Report Date
    October 13, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K161413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO UF REPORT # (B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 09/14/2020. 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. PER THE INITIAL REPORTER NO DEVICE IS AVAILABLE FOR EXAMINATION. SINCE THE DEVICE WAS NOT RETURNED, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED AND DEVICE FAILURE CANNOT BE CONFIRMED AT THIS TIME. NO LOT NUMBER INFORMATION WAS AVAILABLE SO A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED FOR THE RELATED LOT. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. COMPLAINT # (B)(4) WAS ASSIGNED TO THIS REPORT.

    Description of Event or Problem · 1

    PER THE INITIAL REPORTER'S DESCRIPTION FROM REPORT #: (B)(4): "DESCRIBE THE EVENT OR PROBLEM: WHILE HOLDING INFANT, MOTHER NOTICED WARM AND WET SPOT IN INFANT'S ABDOMEN. MOTHER PLACED INFANT BACK TO CRIB AND NOTIFIED BEDSIDE RN. RN FOUND THAT G-TUBE HAD COME OUT OF PATIENT. PEDI-SURG TEAM ARRIVED AT 0815 TO PLACE NEW ENFIT 14 FR G-TUBE AND INFLATED BALLOON TO 4ML. FORMER G-TUBE EXAMINED AND OBSERVED BALLOON BURST. WE HAVE AT LEAST 8 SIMILAR EVENTS OVER THE PAST 5 MONTHS WHERE THE BALLOON HAS RUPTURED, CAUSING THE TUBE TO FALL OUT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: ENTERAL FEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134273 AMT MINI ONE(R) TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-XXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO