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

Model Number SM1-5-1255

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

Rn administered medication and sterile water flush through gtube mic-key extension without a problem.Rn turned to get feeding syringe and when she turned back toward the patient saw that the whole gtube button and extension was out of the patient on the bed.The balloon button appeared to be completely deflated.Rn immediately put a red rubber catheter in the hole to maintain patency.A replacement balloon button was inserted easily into place.An abdominal xray was done to confirm placement prior to feeds being resumed.2 rns were present and examined the old balloon button.The balloon did not appear to be holding the correct shape/was easily disformed.

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 13497180
• MDR Text Key: 285338541
• Report Number: 13497180
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071119904
• UDI-Public: 00842071119904
• 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: 02/02/2022

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 Model Number: SM1-5-1255
• Device Catalogue Number: SM1-5-1255
• Device Lot Number: 210909-252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1