MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT MINI-ONE GT 12FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Break (1069); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 04/08/2020

Event Type  malfunction  

Event Description

Patient had gastrointestinal tube (gt).Patient's mother was changing the dressing and the patient passed gas and the tube dislodged.Rn called to the bedside and placed gauze dressing over site.Cardiac medical team made aware, general surgeon made aware and to the bedside.General surgeon & nurse able to place catheter into tract and then replaced with same gt that had been dislodged.Patient requiring kidney, ureter, and bladder, and gt study.Upon assessment of the dislodged tube it was found that the balloon was not intact and when water was inserted into the tube there was a notable leak.Plan to follow up with defective product and notify enteral tube service.

• Brand Name: AMT MINI-ONE GT 12FR X 1.5CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 10060985
• MDR Text Key: 191107200
• Report Number: 10060985
• 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: 05/07/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA