MAUDE Adverse Event Report: AMT -APPLIED MEDICAL TECHNOLOGY INC AMT MINI ONE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Break (1069); Deflation Problem (1149)

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

Event Date 05/17/2019

Event Type  malfunction  

Event Description

Patient presented to gastrointestinal clinic for routine visit.Patient's parent noted issue with checking water in amt mini one g-tube balloon.Nurse assessed, unable to pull any water out of balloon or instill any water.Valve of balloon port noted to be broken.Tube had recently been changed out 1 month ago.Provider called into room to assess, requiring use of needle to puncture stem of tube to drain water from balloon.This was successfully completed, and new tube was placed.This has been an ongoing issue with amt tubes.

• Brand Name: AMT MINI ONE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AMT -APPLIED MEDICAL TECHNOLOGY INC; 8006 katherine boulevard; brecksville OH 44141
• MDR Report Key: 9290314
• MDR Text Key: 165475270
• Report Number: 9290314
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 730 DA