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

Model Number M1-5-1208

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report is a response to report # (b)(4) which was received by amt from the fda on 05/07/2020.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 retrieve the device for examination and additional information regarding the report.The device was received for analysis on 05/21/2020 and was inspected in our lab in addition to a dhr review of the manufactured lot number.Our examination determined no indication that a manufacturing defect occurred and no similar reported failures have occurred from this same manufactured batch of product.Based on the provided information, a dhr review, and analysis of the device, the reported problem is not believed to have been caused by a manufacturing defect.Complaint # (b)(4) was assigned to this report.The reported complaint and analysis has been logged into our complaint database and will be used for trending of complaints to incorporate into future product enhancements if deemed necessary.

Event Description

Per initial report #: (b)(4): "patient's 12fr amt g-tube fell out during hands on care.Balloon on g-tube that fell out was deflated.Balloon was tested after it fell out and was leaking.".

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: GASTROSTOMY TUBE
• 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: 10124580
• MDR Text Key: 210636645
• Report Number: 1526012-2020-00008
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: M1-5-1208
• Device Catalogue Number: M1-5-1208
• Device Lot Number: 180920-366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 2 MO
• Patient Weight: 3