BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE BALLOON BUTTON

    MDR report key: 14279451 · Received May 4, 2022

    Report

    Report Number
    1526012-2022-00006
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    February 26, 2022
    Report Date
    May 3, 2022
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K161413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A RESPONSE TO UF REPORT # (B)(4) WHICH WAS RECEIVED BY AMT ON 04/04/2022. 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 WORKED WITH THE ORIGINAL REPORTER TO OBTAIN THE DEVICE FOR EXAMINATION AND PERFORMED AN INSPECTION OF THE DEVICE ON 04/26/2022. A TEAR IN THE BALLOON WALL WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS COMPLETED FOR THE REPORTED LOT NUMBER AND NO ANOMALIES WERE FOUND AND THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING TEARS OR RUPTURES FROM THIS SAME BATCH. THE REPORTER INDICATED THAT THE DEVICE WAS IN USE FOR 130-DAYS PRIOR TO THE RUPTURE OF THE BALLOON. HOWEVER, IT WAS ALSO DETERMINED THAT THE LASERED LOT NUMBER ON THE RETURNED DEVICE WAS FROM A BATCH MANUFACTURED AFTER THE INDICATED 10/19/2021 PLACEMENT DATE. THEREFORE, EITHER THE REPORTED LONGEVITY IS INCORRECT, OR THE WRONG DEVICE WAS RETURNED. EITHER WAY, THE ACCURACY OF THE REPORTED INFORMATION IS IN QUESTION. 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 · 0

    PER THE ORIGINAL REPORTER IN UF/IMPORTER REPORT #: (B)(4), IT WAS REPORTED THAT "A VISITOR WAS HOLDING THE PATIENT WHEN SHE NOTICED A WET SPOT AND THEN, MOM SAW THAT THE G TUBE WAS OUT OF THE PATIENT. ONCE PATIENT WAS BACK TO BED, RN LOOKED AT THE TUBE AND THE BALLOON WAS CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473205 MINI ONE BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1215-I 210909-252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown