MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M1-5-1215-I

Device Problems Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.".

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 14279451
• MDR Text Key: 294642301
• Report Number: 1526012-2022-00006
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M1-5-1215-I
• Device Catalogue Number: M1-5-1215-I
• Device Lot Number: 210909-252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1