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

Model Number SM1-5-1255

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

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

Event Date 02/16/2022

Event Type  malfunction  

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 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
• 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: 13775606
• MDR Text Key: 291958649
• Report Number: 1526012-2022-00004
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071119904
• UDI-Public: (01)00842071119904
• 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: 03/15/2022

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
• Device Operator: Health Professional
• Device Model Number: SM1-5-1255
• Device Catalogue Number: SM1-5-1255
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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