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

Model Number	42-7366
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.A photo of the device was provided by the customer.All information reasonably known as of 28 jul 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.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.
Event or Problem Description
It was reported that the weighted end of the ng [nasogastric] tube had "broken off." the tube was removed including the weighted part "which was still attached by the smallest margin." no patient injury was reported.Additional information received 13-july-2020 indicated that "nj [nasojejunal] tube passed on a patient that required nj feeding.On x-ray to confirm tube position it showed that the 4.5cm of tube below the weighted part had broken.Nj tube removed once patient back from x-ray.The broken part of the tube was hanging on by a thread.Nil part of the tube remained in the patient." patient required another nj tube to be passed and therefore a further x-ray to confirm position.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A photo of the device was provided by the customer.The photo confirmed the reported incident; however, the root cause could not conclusively be determined.All information reasonably known as of 16 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.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The returned sample was examined showing that the tubing had signs of damages, breaking at the tip area.The separated/ broken piece was returned with the sample tube.Further examination and inspection was performed and appears that the tungsten weights portion of the bolus tip broke off from the entire tip.Under magnification (50x), the breaking points were examined and exhibited jagged appearance breaking points.Root cause could not be conclusively determined.All information reasonably known as of 18 mar 2021 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: 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
• MDR Report Key: 10335041
• Report Number: 9611594-2020-00137
• Device Sequence Number: 11031300
• Product Code: KNT
• UDI-Device Identifier: 20815149020574
• UDI-Public: 20815149020574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2021

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: 42-7366
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 02/24/2021
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/16/2020; 03/19/2021
• Patient Sequence Number: 1
• Patient Age: 20 MO
• Patient Weight: 10