MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON; LOW PROFILE GASTROSTOMY BALLOON BUTTON

Model Number M1-5-1208

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is a response to report # 3933070000-2020-8006 which was received by amt on (b)(6) 2020.Based on the provided information, the incident 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 has reached out to the customer in attempts to retrieve the device for examination and additional information regarding the report.It was determined that no device was available for return in response received from the reporter.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 done on the reported lot number found no anomalies in production or similar complaints reported from the same batch.Based on the provided information, the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.

Event Description

Per medwatch report #: 3922070000-2020-8006: " patient gastric tube (gt) was noted out and laying in bed after working with pt during first care.Pt was vocal about a previous history of the gt becoming dislodged during multiple/different times and stated would be extra careful of this during therapy.Also stated in report gt became dislodged multiple times over 2-week period.Balloon on gt looked malfunctioned.No bleeding.Gt called gt mini one balloon button low profile feeding device.12 french 0.8 cm lot number 180920-366.Expiration 07/01/2021.Surgical fellow notified immediately by phone and came to reinsert a brand-new gt.I explained what happened and that surgical fellow came to bedside and up sized her gt to a 12 french 1.2 cm gt without incident.No bleeding to site.Resident teammate notified and expressed she would relay info to nurse practitioner.Discussed with orange team incident of gt becoming dislodged during rounds in front of surgical fellow.".

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: LOW PROFILE GASTROSTOMY BALLOON BUTTON
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville, oh
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville, oh
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, oh ; 7174000252
• MDR Report Key: 10125128
• MDR Text Key: 199089206
• Report Number: 1526012-2020-00009
• Device Sequence Number: 1
• Product Code: KNT
• 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: 05/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: M1-5-1208
• Device Catalogue Number: M1-5-1208
• Device Lot Number: 180920366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 3 MO
• Patient Weight: 4