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

Model Number M151208

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Skin Irritation (2076)

Event Date 02/09/2020

Event Type  malfunction  

Event Description

Infant noted to have redness around gtube.While feeding was running, noted leakage around the gtube and it came out.When verified the balloon, noted to have tear and not inflating.Fda safety report id# (b)(4).

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 9707137
• MDR Text Key: 179502853
• Report Number: MW5092990
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071100001
• UDI-Public: 00842071100001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M151208
• Device Catalogue Number: M1-5-1208
• Device Lot Number: 10447607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 MO
• Patient Weight: 3