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

Model Number	SM1-5-1255
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a response to uf report # (b)(4) which was received by amt from the fda on 02/14/2022.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 reached out to the customer to confirm that the product was manufactured by amt and setup a rma to obtain the device for examination.The device has not been returned at the time of this report.Since the device was not returned, a visual and functional evaluation could not be performed and device failure cannot be confirmed at this time.A device history review was completed for the reported lot number, but it was found that the lot number does not match the provided part number / gtin number.Therefore the reporter's information on part number or lot number is believed to be incorrect.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 report received by amt in uf report #: (b)(4), "rn administered medication and sterile water flush through gtube mic-key extension without a problem.Rn turned to get feeding syringe and when she turned back toward the patient she saw that the whole gtube button and extension was out of the patient on the bed.The balloon button appeared to be completely deflated.Rn immediately put a red rubber catheter in the hole to maintain patency.A replacement balloon button was inserted easily into place.An abdominal xray was done to confirm placement prior to feeds being resumed.2 rns were present and examined the old balloon button.The balloon did not appear to be holding the correct shape/was easily disformed.".

• Brand Name: MINIONE 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 ; 4407174000
• MDR Report Key: 13775606
• Report Number: 1526012-2022-00004
• Device Sequence Number: 15038035
• Product Code: KNT
• UDI-Device Identifier: 00842071119904
• UDI-Public: (01)00842071119904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/15/2022

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: 08/01/2024
• Device Model Number: SM1-5-1255
• Device Catalogue Number: SM1-5-1255
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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