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

Model Number	0230-14-3.0
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the tube failed/broke; the other half had to be retrieved endoscopically.There was no reported injury additional information received 16nov2022 reported, the tube had been in place for no more than 2 weeks and the patient was reportedly in ¿fine condition¿.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 07 dec 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.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.
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation; the provided sample was received in two pieces.The breaking point was viewed under magnification (20x) and was noted to have jagged edges.Additionally, it appeared that there were missing tubing pieces due to the separation points not matching when an attempt was made to re-form the tubing together.Testing of the sample was not possible due to the device not being able to be filled with the suggested amount of water due to the breakage.The reported event could be confirmed, the break caused the device to be unable to function as intended; however, the root cause was not undetermined.The device history record for lot 30196000 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 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 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: DH EF BALLOON TUBES PRODUCTS
• Common Device Name: MIC-KEY JEJUNAL FEEDING TUBE KIT
• 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: 15946057
• Report Number: 9611594-2022-00149
• Device Sequence Number: 20667757
• Product Code: KNT
• UDI-Device Identifier: 00350770954639
• UDI-Public: 00350770954639
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K853197
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: Health Professional
• Device Expiration Date: 05/17/2024
• Device Model Number: 0230-14-3.0
• Device Lot Number: 30196000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 67 KG