MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC JEJUNAL FEED TUBE, ENFIT CONNECTOR-14 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8200-14
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a radical total gastrectomy on (b)(6) 2022, with jejunostomy feeding tube inserted into the jejunum directly through the skin on the abdomen.The patient was "diagnosed with intraabdominal sepsis and small bowel pressure necrosis caused by pressure from the feeding jejunostomy balloon and 21ml of fluid was found in the balloon." a computed tomography (ct) was completed that was highly suspicious for bowel ischemia.Patient had a laparotomy, washout, removal of feeding jejunostomy with small bowel resection and anastomosis.A review found that at some time during admission (time unable to be determined) a syringe was inserted into the balloon port instead of the feeding port and a water flush entered the balloon, inflating it to 21mls.The inflated balloon was immobile and exerted pressure on the small intestine wall which caused small bowel pressure necrosis and localized peritonitis.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2023 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The device history record for the reported lot number, 20058951, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 19-jan-2024 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: MIC JEJUNAL FEED TUBE, ENFIT CONNECTOR-14 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18245590
• Report Number: 9611594-2023-00166
• Device Sequence Number: 12433732
• Product Code: KNT
• UDI-Device Identifier: 00350770445670
• UDI-Public: 00350770445670
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K853197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 8200-14
• Device Catalogue Number: N/A
• Device Lot Number: 20058951
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown