MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 FR,; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-14-2.7
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A partial device was returned to the manufacturer for evaluation, where it was determined that the balloon end of the tube had broken off and was missing from the sample.The investigation remains in progress at this time.The device history record for lot 30046423 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 apr 2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the feeding tube fell out of the patient but that the balloon broke and the pieces left inside.No further clarification was able to be provided at that time.Per information received 29 mar 2022 based on the evaluation the sample, it was determined that the tube had broken off completely.Per additional information received on 8 apr 2022 from the original reporter, there has been no report of the broken off piece being passed naturally, however no medical intervention has been required.The doctor determined that it should pass naturally eventually.
Additional Manufacturer Narrative
The device was evaluated.The sample provided was evaluated confirming the tube breaks on the piece of tube attached to the molded head.However, per dhr review and process assessment conducted, there were no activities or tools identified that could cause this type of damage in the tube of mic-key, therefore, the root cause for this incident could not be conclusively determined or associated to the manufacture device.In addition, there was an expiration date of three days after when the device involved had expired.Root cause could not be determined.All information reasonably known as of 20-jun-2022 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 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, EXTENSION SETS WITH ENFIT CONNECTORS - 14 FR,
• 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: 14163598
• Report Number: 9611594-2022-00045
• Device Sequence Number: 12201228
• Product Code: KNT
• UDI-Device Identifier: 00350770427348
• UDI-Public: 00350770427348
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 03/01/2022
• Device Model Number: 8140-14-2.7
• Device Catalogue Number: N/A
• Device Lot Number: 30046423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 52 KG