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

Model Number	42-9366
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601); Obstruction of Flow (2423)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2023
Type of Reportable Event	Malfunction
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 an exact lot number not was provided.All information reasonably known as of 30 oct 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.
Event or Problem Description
It was reported, the nasojejunal tube (njt) had been placed since (b)(6) 2023 and had an occlusion alarm at approximately 0715 on (b)(6) 2023.At 0745, unable to flush njt.Abdominal x-ray confirmed position in distal duodenum and that the njt was blocked and required replacement.Staff attempted to remove but met a lot of resistance.Steady traction applied for intervals of 20-30 seconds.The njt was moved approximately 6cm and stopped again.Further steady traction applied and the proximal end of njt came away.The proximal end had a dilated appearance, like a burst balloon.Estimated 20cm of the ngt still left internally.The patient was stable.¿re- x-ray showed tip of njt at level of pylorus and length of tube the entire length of oesophagus query up to oral cavity.Examination with tongue depressor did not show an obvious tip.¿ the impression of the nj tube was ¿degradation/defect causing dilation/blockage at breakage point of njt.¿ medical treatment included, ¿commenced on iv fluids.X-ray showed tip of njt at level of pylorus and length of tube the entire length of oesophagus query up to oral cavity.Decision to trial visualisation with direct laryngoscopy/video laryngoscopy.On gentle direct laryngoscopy tip easily visualised and dislodged by mcgills forceps, infant had gag reflex and tip of tube appeared at mouth opening.Easily removed without any resistance in entirety, tip visualised.¿ the patient was reported to be stable.The nj tube was in-use for 66 days.
Additional Manufacturer Narrative
H6: investigation findings: appropriate term/code not available: malfunction observed without conclusive finding.The device history record for lot 30211310 was reviewed and the product was produced according to product specifications.The product involved in the report has been returned.The sample provided confirms tubing expanded to form a balloon shape which burst causing a separation of the tube.The incident was confirmed as reported.However, per complaint comments, the tube was already used for 2 months, therefore, the failure reported might not be associated to the manufacturing process.Ifu contains recommendations for tube maintenance: ¿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.¿ a root cause could not be determined.All information reasonably known as of 28 nov 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.
Event or Problem Description
The tube was in place since (b)(6) 2023.

• 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: 18051836
• Report Number: 9611594-2023-00152
• Device Sequence Number: 8077865
• Product Code: KNT
• UDI-Device Identifier: 00350770460918
• UDI-Public: 00350770460918
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: Health Professional
• Device Model Number: 42-9366
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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: 3 MO
• Patient Sex: Male
• Patient Weight: 5 KG