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

Model Number	M1-5-1208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Mini one balloon button was leaking in pt, it was removed from the pt and found to have a tear and not inflating.Staff obtained a new mini one balloon button and tested it at bedside before inserting it in the pt.The new balloon was found to have a tear and would not inflate.This report is for the new balloon that was tested at bedside and was defective.Fda safety report id# (b)(4).

• Brand Name: MINI ONE BALLOON BUTTON
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 9720566
• Report Number: MW5093015
• Device Sequence Number: 2513127
• Product Code: KNT
• UDI-Device Identifier: 00842071100001
• UDI-Public: (01)00842071100001(17)220601(10)190913-221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: No Information
• Device Expiration Date: 06/01/2022
• Device Model Number: M1-5-1208
• Device Catalogue Number: REF: M1-5-1208
• Device Lot Number: 190913-221
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO
• Patient Weight: 3