MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT; DH EF BALLOON TUBES PRODUCTS

Model Number	0250-16
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.All information reasonably known as of 05 may 2025 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 reported event but is relaying the information 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).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.
Event or Problem Description
It was reported, "last year the tube tried to come out of her throat after balloon rupture.¿.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30303981, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One used sample was received the product packaging was not received.After cleaning decontamination, the sample was examined in a well lit area.The sample was received in two pieces.The tubing is severed approximately 5.5cm below the base of the molded head.No obvious hole or tear was observed in the balloon.There was brown buildup inside the jejunal and gastric lumens.The print on the head was degraded.Many of the depth markers on the tubing are also faded and degraded.There was a slight crimp in the tubing at the 3cm marker.The outer surface of the tubing exhibited slight deformation with ridges and bumps, along the gastric lumen.Balloon inflation could not be assessed since the tubing has been cut.Root cause could not be determined.All information reasonably known as of 19-sep-2025 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 comp (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 GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT
• 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: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21970646
• Report Number: 9611594-2025-00089
• Device Sequence Number: 8480813
• Product Code: KNT
• UDI-Device Identifier: 00350770954806
• UDI-Public: (01)00350770954806
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K921370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2026
• Device Model Number: 0250-16
• Device Catalogue Number: 0250-16
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Patient Sex: Female