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

Model Number	8100-18
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the cap ¿pops¿ off and gastric fluid leaks out, causing quite serious lesions on the skin.Per additional information received on (b)(6) 2024, tube was replaced with one from another manufacturer and the burn injuries were treated with antiseptic and healing cream.The patient¿s status was reported ¿stable state and the burn injuries were almost eliminated today.¿ per additional information received on (b)(6) 2024, antiseptic and healing cream were prescribed products and not over-the-counter products.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided; therefore, the udi-pi is unavailable.The actual complaint product was not returned for evaluation.All information reasonably known as of 18 jun 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 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.

• Brand Name: MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS
• 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 84048 ; MX 84048
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19574530
• Report Number: 9611594-2024-00113
• Device Sequence Number: 8409717
• Product Code: KNT
• UDI-Device Identifier: 00350770442938
• UDI-Public: (01)00350770442938
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: Other
• Device Model Number: 8100-18
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 34 YR
• Patient Sex: Male
• Patient Weight: 65 KG