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

Model Number	40-7438
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4581-appropriate clinical signs, symptoms, conditions term/code not available: white mucous.H6: 4581-appropriate clinical signs, symptoms, conditions term/code not available: retching.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 24 may 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 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.
Event or Problem Description
Fda user facility report mw report (b)(4) received reported, patient had been having white mucous balls in stool and retching overnight.Team decided to remove ndt (nasoduodenal (nd) feeding tube) to replace.Ndt had been in place approximately 2 months.Upon removing tube, end of tube was not intact, looked like the tube disintegrated and about 1cm of tube was missing.Kub (kidney, ureter, and bladder x-ray) was obtained, and part of the weighted tip was visible.(corflo nasogastric feeding tube 8fr 109cm).No patient harm, bowel movement included passing of retained ng tube piece.
Additional Manufacturer Narrative
Correction h10: a review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 14 jun 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 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 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET 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: 17006010
• Report Number: 9611594-2023-00078
• Device Sequence Number: 17728068
• Product Code: KNT
• UDI-Device Identifier: 00350770460345
• UDI-Public: 00350770460345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: 40-7438
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/16/2023
• 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: 1 YR
• Patient Sex: Female