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

Model Number M1-5-1417-I

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

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

Event Date 01/30/2022

Event Type  malfunction  

Manufacturer Narrative

This report is a response to uf report # (b)(4) which was received by amt on 02/16/2022.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 02/28/2022.A tear in the balloon was identified and an unknown substance was noted in the balloon inflation port which may be an indicator that the user incorrectly accessed the port and caused the failure of the balloon.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaint reports for this same batch.An amt representative also visited the site of the original reporter on 03/08/2022 and several possible causes of failure were noted during our visit, including high hospital staff turnover and lack of training, tension applied during use, lack of removal of extension sets while device not in use, and misuse of the device.The reporter is moving forward with several internal changes to help prevent future failures and implementing more thorough training of staff.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 event reported in uf report #: (b)(4), "patient had a cecostomy tube placed 8 days prior to the event.The device placed was an amt 14 fr 1.7cm length button.Two days later, the tube was found dislodged from patient.The balloon that was holding the tube in place was ruptured.The pediatric surgery resident replaced it at bedside with another tube as a placeholder.The patient did require a new tube to be placed under fluoroscopy with interventional radiology.".

• Brand Name: MINIONE 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: 13807424
• MDR Text Key: 293141071
• Report Number: 1526012-2022-00005
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071113971
• UDI-Public: 00842071113971
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: M1-5-1417-I
• Device Catalogue Number: M1-5-1417-I
• Device Lot Number: 210712-175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• 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
• Patient Age: 6 YR
• Patient Sex: Male