MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 18 FR, 2.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-18-2.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Serious Injury
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 30 oct 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 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 21 cfr 803, 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, ¿serious redness and skin burning occurred.A lab culture was taken.Culture showed moderate growth of yeast candida.Packaging was verified intact.Filtered water was used 5.0ml.Due to the sample being processed in lab it was disposed as biohazardous under suspicion of bacterial and or viral contamination.It was held during the time the cultures were processing however the cultures were finished as of this morning and the physician team did not check the ¿return samples to clinic¿ box on the lab forms.The sample cannot be retrieved however the lab report can be provided.Antifungal intervention was required.No hospital involvement outpatient clinic ¿ dermatology.Nystatin 100,000u cream for 3 weeks to the peg site to eradicate any yeast organisms.[the patient is] stable condition being managed by home intervention with telehealth servicing approx.Weekly.¿.
Additional Manufacturer Narrative
Correction: h4.Additional information: h10.The device history record for lot 30209297 was reviewed and the product was produced according to product specifications.A root cause could not be determined.All information reasonably known as of 19 mar 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-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE - 18 FR, 2.7 CM
• 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: 18049536
• Report Number: 9611594-2023-00154
• Device Sequence Number: 18017373
• Product Code: KNT
• UDI-Device Identifier: 00350770948881
• UDI-Public: 00350770948881
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 07/11/2024
• Device Model Number: 0120-18-2.7
• Device Catalogue Number: N/A
• Device Lot Number: 30209297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NYSTATIN CREAM 100,000U X 3 WEEKS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 56 KG