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

Model Number	42-7558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18 feb 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the patient's nasojejunal feeding tube ballooned in the nostril.It was left in place, unused, until replacement could be performed.However, once removed in radiology, it was found the tube had broken and approximately 30cm of tubing remained in the patient.The fragment was removed endoscopically.It was noted in the patient's notes that the tube had blocked on (b)(6) 2020, but the nurse had used a small enteral syringe to flush and remove the block.There was nothing notable about the patient's condition following the endoscopic removal.
Additional Manufacturer Narrative
Correction: the lot number originally provided was found to not be valid.The customer provided a corrected lot number on 25 feb 2020.The device history record for lot 0002960681 was reviewed and the product was produced according to product specifications.One used sample was returned for evaluation.The tube was observed to have foreign substance in the inner lumen.There was a ballooned area on the tube which exhibited a complete burst/tear.The portion of the tube distal to this burst was not returned with the sample.The edges of the burst/tear were examined and found to have an area where the tear was jagged in appearance.The complaint was confirmed as reported, however, no root cause could be determined.All information reasonably known as of 09 mar 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 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 CONNECTO
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9726547
• Report Number: 9611594-2020-00030
• Device Sequence Number: 2460589
• Product Code: KNT
• UDI-Device Identifier: 20815149020598
• UDI-Public: 20815149020598
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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 Expiration Date: 11/01/2023
• Device Model Number: 42-7558
• Device Catalogue Number: N/A
• Device Lot Number: 0002960681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 52