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

Model Number	8140-12-2.0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, a leakage was noticed during feeding; it was apparent the port had detached from the balloon (the balloon remained inside the patient¿s stomach).Per additional information received on 13jan2023, a plug was inserted, and the doctor confirmed the patient will eventually pass the piece in a bowel movement; the patient was reportedly doing well.Per additional information received on 20jan2023, the patient passed the retained piece through a bowel movement.No harm or interventions were taken.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The sample is reported to be available but has not yet been received by the manufacturer.All information reasonably known as of 24 jan 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 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
Correction: h6 health effect - clinical code.The product involved in the report has been returned, and the investigation remains in progress at this time.A review of the device history record is in-progress.All information reasonably known as of 15 mar 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 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 lot 30181421 was reviewed, and the product was produced according to product specifications.The actual complaint product was returned for evaluation.After decontamination, the sample was examined in a well-lit area.The molded head appeared clean, without foreign material on the device's exterior.The tube and balloon were missing and were not returned with the sample.The attachment point for the tube was examined under magnification, and a possible adhesive residue was photographed.The balloon could not be evaluated for a burst due to not being returned.The sample confirms the feeding tube was detached/separated from the silicone molded head; however, a root cause could not be determined.All information reasonably known as of 08 may 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 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
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16233341
• Report Number: 9611594-2023-00015
• Device Sequence Number: 17772627
• Product Code: KNT
• UDI-Device Identifier: 00350770427164
• UDI-Public: 00350770427164
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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 Expiration Date: 02/02/2024
• Device Model Number: 8140-12-2.0
• Device Lot Number: 30181421
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 02/21/2023; 05/05/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/16/2023; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 22 KG