MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO PEG JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR; DH CPK JEJUNOSTOMY PRODUCTS

Model Number	50-7366
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Foreign Body In Patient (2687)
Date of Event	12/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, a corflo peg jejunostomy tube broke into multiple pieces in the body, requiring endoscopic retrieval under general anesthesia, and subsequently caused respiratory distress.Per additional information provided on 25 jan 2024, the patient was discharged home after a 32-day admission.
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2024 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as comp (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
Correction: h10: the actual complaint product is not available to be returned for evaluation.Additional information: b5, h6.All information reasonably known as of 06 mar 2024 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as (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
Per additional information received on 23-feb-2024, ¿when examining the removed tube, a portion of the tube remained in the body, specifically in the lower esophagus.This was confirmed on x-ray which showed one tip of the tube in the right upper quadrant and the other likely within the mid esophagus.¿.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 26 mar 2024 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as comp-(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
H6: investigation findings: 4247 - appropriate term/code not available: blockage identified.H6: investigation findings: 4247 - appropriate term/code not available: usage problem identified.The customer provided photos of the alleged device which confirmed the tubing expanded to form a balloon shape, which burst, causing a separation of the tube.The burst shape in the tube is provoked by the clog in the tube.However, process evaluation and tools are in right conditions and there were no activities that could identified the cause of this type of damage in this particular device incident.The reported failure is more likely associated to user/inappropriate use of the product.Instructions for use calls for: tube maintenance 1.Follow your institution/facility/hospital protocol or clinician¿s order.2.It is recommended the tube be irrigated every 4 hours with up to 20 ml of water (up to 10 ml for infants or children) before and after medication administration or when feeding formula is interrupted.Warning: vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube.All information reasonably known as of 10 apr 2024 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as (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: CORFLO PEG JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: DH CPK JEJUNOSTOMY 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: 18684176
• Report Number: 9611594-2024-00011
• Device Sequence Number: 6934104
• Product Code: KNT
• UDI-Device Identifier: 00350770462271
• UDI-Public: 00350770462271
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K882867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2024

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 Model Number: 50-7366
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 02/23/2024; 03/07/2024; 04/08/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/08/2024; 03/28/2024; 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 17 YR
• Patient Sex: Male
• Patient Weight: 14 KG