MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOINTESTINAL ENDOSCOPICALLY PLACED FEEDING TUBE WITH ENFIT CONNECTOR; DH CPK NG TUBES

Model Number	50-4602
Medical Device Problem Codes	Unintended Movement (3026); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the nasojejunal tube ruptured after two months.The patient contacted the department on (b)(6) 2023 and an x-ray confirmed the rupture.The lower end of the tube was in the stomach instead of the intestines.Endoscopic insertion of another tube was performed with radiological control of correct positioning with opacification.The patient's status was reported to be ¿correct".No injury reported.
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 not possible as no lot number was provided.All information reasonably known as of 17 jul 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 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 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
Additional information: h6 the actual complaint product was returned for evaluation.Product packaging was not received.The product does not contain a lot number identification.The sample was examined in a well-lit area.The 2-port enfit connector is attached at the proximal end of the tubing.The connector does not exhibit visible damage.The connection appears to be secure.There is evidence of ballooning of the tubing.Central to the ballooned area, the tubing is severed.The distal portion was not returned.The outside of the tubing is discolored, becoming darker nearer to the ballooned area.The print on the tubing is faded and cannot be read, even under magnification.Water was infused through the central port, using an enfit syringe.The water flowed without restriction.The root cause of the reported issue could not be conclusively determined; however, the investigation noted this seemed to be a user-related problem since as per the instructions for use (ifu), vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.Per incident comments, the device was in use for a period of time (60 days); which, indicates that the device did not show this defect at the time of placement and the tube performed as intended.All information reasonably known as of 11 sep 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 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 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 product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 08 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 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 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: CORFLO NASOINTESTINAL ENDOSCOPICALLY PLACED FEEDING TUBE WITH ENFIT CONNECTOR
• Common Device Name: DH CPK NG TUBES
• 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: 17333284
• Report Number: 9611594-2023-00099
• Device Sequence Number: 7361378
• Product Code: KNT
• UDI-Device Identifier: 00350770461946
• UDI-Public: 00350770461946
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K821906
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2023

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: Other
• Device Model Number: 50-4602
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/18/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/08/2023; 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male
• Patient Weight: 62 KG