MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE KIT (ENFIT); DH EF BALLOON TUBES PRODUCTS

Model Number	8140-14-1.5
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erythema (1840); Granuloma (1876); Fungal Infection (2419); Skin Infection (4544)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.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 29 jul 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.
Event or Problem Description
It was reported, gastronomy site leaking and surrounding skin red.Patient developed granuloma.Small mushroom type growth on shaft.Child well in herself.No pyrexia, vomiting or other symptoms.Device originally placed in hospital.Changed every 4 months by parents.Per additional information received on 02jul2024, the device was reported as placed in (b)(6), the problem was noticed on (b)(6) 2024 and was subsequently removed on (b)(6) 2024.Per additional information received on 03jul2024, ¿the skin swab grew light growth of yeast and moderate growth of staphylococcus aureus.Preliminary result shows the aspirate has grown yeasts.Gram negative bacilli.Culture mixed growth including heavy growth of candida albicans.One of our paediatric consultants prescribed appropriate treatment, both topical and systemic.The patient is well in herself.¿.
Additional Manufacturer Narrative
A review of the device history record and udi are in-progress.The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of (b)(6) 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.
Additional Manufacturer Narrative
Additional information: the device history record for lot 30148919 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Subject sample provided was evaluated, there were crusty and brownish foreign material present.This is a non-production related incident.According to complaint comments, since the device was in use for an extended period of time within 90+ days, which, indicates that device did not show this defect at time of placement and the tube performed as intended.A root cause could not be determined.All information reasonably known as of 22 jul 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.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE KIT (ENFIT)
• 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: 19862283
• Report Number: 9611594-2024-00142
• Device Sequence Number: 15334448
• Product Code: KNT
• UDI-Device Identifier: 00350770427270
• UDI-Public: (01)00350770427270(240)104272702(11)210727(17)230727(10)30148919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: Lay User/Patient
• Device Expiration Date: 07/27/2023
• Device Model Number: 8140-14-1.5
• Device Catalogue Number: N/A
• Device Lot Number: 30148919
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 07/01/2025
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/10/2024; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 25 KG