MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GJ FEEDING TUBE, ENFIT ENDO/RADIO PLACED; DH EF BALLOON TUBES PRODUCTS

Model Number	8250-22
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the probe has already begun to malfunction; it began to filter through tortuosities what is happening through the gastro." it was noted the device appears to have what looks like intestinal tissue migrating into the feeding tube channel.The tube itself has no report of any deficiencies, but there is definite foreign material in the tube channel.The patient was administered an extensive list of medications through the device.Additional information received 15-aug-2023 stated the patient was at home.The device was flushed with water 10cc before and after each use.The gastric-jejunal are both used.The device was not attached to suction.The event occurred gradually.There was no record of the patient undergoing any procedures previous to this incident.There was no record of separation of intestines.There was no record of any intestinal worms.The patient is reported to be an alert, conscious patient, oriented with sequelae of covid 19 by pulmonary fibrosis, with dependence on mechanical ventilation, persistence of gastroesophageal reflux, because he requires an advanced feeding tube to jejunum.That particular feeding tube had been in place for approximately 3-months.A new feeding tube was placed.Additionally, he patient has been presented with this same event on several occasions the feeding tube presented dilations and subsequent perforation that requires feeding tube change.
Additional Manufacturer Narrative
H6 health effect - clinical code: foreign material in the tube channel.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 25-aug-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.H3 other text: device not returned.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30213045, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.An image was provided by user facility and the incident was confirmed.However, this seems to be a non-production related incident.Since per incident comments, the device was in use for an extended period of time (60-90 days); which, indicates that device did not show this defect at time of placement and the tube performed as intended, it is not possible to know the conditions that the device was exposed to in that period of time.The root cause of the reported issue has not been conclusively determined.All information reasonably known as of 14-feb-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 GJ FEEDING TUBE, ENFIT ENDO/RADIO PLACED
• 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: 17631089
• Report Number: 9611594-2023-00121
• Device Sequence Number: 6473256
• Product Code: KNT
• UDI-Device Identifier: 00350770445489
• UDI-Public: 00350770445489
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K921370
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 09/27/2023
• Device Model Number: 8250-22
• Device Catalogue Number: N/A
• Device Lot Number: 30213045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 64 KG