MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT®CONNECTORS - 18 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8100-18
Medical Device Problem Codes	Fluid/Blood Leak (1250); Malposition of Device (2616)
Health Effect - Clinical Codes	Abdominal Pain (1685); Ascites (2596)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fda medwatch/user facility report (b)(4).The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 20013598 was reviewed and the product was produced according to product specifications.All information reasonably known as of 04 may 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
Per fda medwatch/user facility report (b)(4), the patient had a percutaneous endoscopic gastrostomy tube placed on (b)(6) 2020.Three t fasteners were placed to anchor the gastric wall against the intra-abdominal wall.An 18fr gastrostomy tube (g tube) was placed and the retention balloon filled with 10cc saline.The patient was discharged from the hospital on (b)(6) 2020.The patient woke up on (b)(6) 2020 with left lower quadrant abdominal pain.Flushing the tube reduced the pain, however, after awaking from a nap the patient experienced "excruciating pain" in the left abdomen that radiated up to the left shoulder.In the emergency department, a ct scan showed "malpositioned displaced g-tube (extraluminal) with mild loculated abdominopelvic fluid and several foci of gas adjacent to the stomach." the g tube was intact through the abdominal wall but was no longer in the stomach.The patient was taken to the operating room on (b)(6) 2020.The t fasteners had been removed a couple days previous.The surgeon reported "a hole/perforation of the posterior stomach along the greater curvature.There was also some purulent fluid in the abdominal cavity." the balloon was found to have only 1 cc of fluid in it.The surgeon tested the balloon by adding additional saline, and no leak was detected.The surgeon placed a new g tube and two purse-string silk sutures.The patient was discharged on (b)(6) 2020.Additional information has been requested but not received.

• Brand Name: MIC GASTROSTOMY FEEDING TUBE WITH ENFIT®CONNECTORS - 18 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10026729
• Report Number: 9611594-2020-00076
• Device Sequence Number: 2592900
• Product Code: KNT
• UDI-Device Identifier: 00350770442938
• UDI-Public: 00350770442938
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 8100-18
• Device Catalogue Number: N/A
• Device Lot Number: 20013598
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 72