MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 1.7 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-16-1.7-22
Medical Device Problem Codes	Break (1069); Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 30029182 was reviewed and the product was produced according to product specifications.Photos of the device were provided by the customer.All information reasonably known as of 02 sep 2020 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).
Event or Problem Description
It was reported that when the patient was in ir [interventional radiology] for a tube change, the tube was removed but the j-portion [jejunal portion] of the tube was broken off and remained in patient¿s jejunum.The patient was able to successfully pass the j-portion in her stool naturally.No patient injury was reported.Additional information received 14-aug-2020 indicated the patient's current status was "stable outpatient." there were no adverse effects related to the incident.The patient required overnight admission and close medical observation.The patient was discharged the next afternoon after passing the j-tube [jejunal tube] extension in bowel movement naturally.The feeding tube was in place for 33 days with the last tube exchange taking place on 05-jul-2020.Both liquids and crushed medications were infused via the tube and there is a history of tube clogging.Clogging was resolved by "syringe push with force." the parent "was advised to use some force to push crushed medication into j-port [jenual port].".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Photos of the device were provided by the customer.Review of the photos confirmed the reported event; however, root cause could not be determined.All information reasonably known as of 17 sep 2020 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 GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS - 16 FR, 1.7 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10485766
• Report Number: 9611594-2020-00169
• Device Sequence Number: 16813430
• Product Code: KNT
• UDI-Device Identifier: 00350770440880
• UDI-Public: 00350770440880
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 02/01/2022
• Device Model Number: 8270-16-1.7-22
• Device Catalogue Number: N/A
• Device Lot Number: 30029182
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 13