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

Model Number	M1-5-1417-I
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4) which was received by amt on 09/06/2022.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.The device wasn't opened or used, as it was returned to amt for examination still sealed.Amt confirmed through the examination of the returned device that a hair was partially wrapped around the button of the device.A device history review was completed for the reported lot number and no anomalies were found and there have been no other complaint reports from this same batch.It is believed that the hair was hidden under a component in the tray during the multiple qc inspections of the product prior to shipment, and moved into a visible area of the tray during shipment.Production and warehouse staff have been notified accordingly of the hair to ensure repeat occurrence is avoided.The complaint information has been logged into our complaint database for trending purposes.Complaint # (b)(4) was assigned to this report.
Event or Problem Description
Per the original reporter in uf/importer report #: (b)(4), " a sterile package with a 14fr x 1.7cm mini one(r) balloon button (boxed kit - isosaf) low profile feeding device that was unopened was found to have a hair that was wrapped around the button portion in the kit.".

• Brand Name: MINI ONE(R) BALLOON BUTTON
• Common Device Name: 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
• MDR Report Key: 15501344
• Report Number: 1526012-2022-00011
• Device Sequence Number: 5439081
• Product Code: KNT
• UDI-Device Identifier: 00842071113971
• UDI-Public: (01)00842071113971(17)241201(10)220104-426
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Model Number: M1-5-1417-I
• Device Catalogue Number: M1-5-1417-I
• Device Lot Number: 220104-426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown