MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE G-TUBE-18 FR, 5.0 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0120-18-5.0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the "tube [was] in place for three months [and] broke between the button and tube part.The tube part slipped through the stoma and into [patient's] stomach.States there are no symptoms.Incident occurred around 11am.[family member] said she was going to try to retrieve the tube with tweezers but didn't want to pinch skin.States when [family member] examined the inside of the stoma, didn't see the tube at all and determined that it slipped into the stomach.States when [family member] replaced the tube, it went in very easily and as expected.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 03-nov-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, inc.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 the reported lot number, 30238700, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The device was evaluated.The original packaging was not returned with the device.The distal portion of the device was not received in the lab, only the molded head was returned.The molded head, tube and balloon appeared to have slight discoloration on the exterior and interior of the device.When the sample was viewed under magnification a tearing effect that appeared jagged was seen on the breaking point (molded head portion).Per incident comments, the device was in use for an extended period of time (90 days); which, indicates that device did not show this defect at time of placement and the tube performed as intended.Root cause could not be determined.All information reasonably known as of 28-dec-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, inc.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: d4.A review of the device history record is in-progress.All information reasonably known as of 22-nov-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, inc.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 G-TUBE-18 FR, 5.0 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: 18075598
• Report Number: 9611594-2023-00159
• Device Sequence Number: 12678922
• Product Code: KNT
• UDI-Device Identifier: 00350770948935
• UDI-Public: 00350770948935
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2023

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: Lay User/Patient
• Device Expiration Date: 12/19/2024
• Device Model Number: 0120-18-5.0
• Device Catalogue Number: N/A
• Device Lot Number: 30238700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 12/11/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/22/2023; 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 76 KG