MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 16 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0250-16
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the reported lot number, 30166126, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation all information reasonably known as of (b)(6) 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, 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.
Event or Problem Description
It was reported the "patient's son reports that his father's g tube appears to be not functioning properly.States he is able to flush the g-tube but flushing contents flow back out of tubing.States this has been happening for about a week, will follow up with proceduralist." the 'patient¿s son confirmed gastric fluid and water backflows from peg tube issue began right before (b)(6) 2022.Patient¿s son stated patient pulled at peg tube a little bit out recently up to where its marked #2 on the tubing.Patient's son as well reported patient had possible infection at the stoma site or the 'hole' area.Patient's son stated the stoma site complication occurred few times since replacement in (b)(6) 2022 a couple of times in (b)(6) 2022 and they would follow up with [the healthcare provider].Patient¿s son stated because patient experienced blood, redness and a white drainage at stoma site and was treated with silver nitrate medication.Patient's son stated each time it recovered and no oral or intravenous antibiotics were prescribed." reporter clarified patient did not have a replacement in (b)(6) 2022 but contrast was used to check placement, duopa tubing was assessed at that time and has not been replaced since initial placement in (b)(6) 2022.
Additional Manufacturer Narrative
Correction: g3.Date received by manufacturer- initial report alert date was (b)(6) 2022 and not (b)(6) 2022.All information reasonably known as of 13-oct-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, 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 GASTRIC-JEJUNAL FEEDING TUBE KIT - ENDOSCOPIC/RADIOLOGIC PLACEMENT - 16 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: 15601462
• Report Number: 9611594-2022-00128
• Device Sequence Number: 2136373
• Product Code: KNT
• UDI-Device Identifier: 00350770954806
• UDI-Public: 00350770954806
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: Lay User/Patient
• Device Expiration Date: 09/27/2023
• Device Model Number: 0250-16
• Device Catalogue Number: N/A
• Device Lot Number: 30166126
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARBIDOPA/LEVODOPA
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male