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

Model Number	42-9368
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0202955176 was reviewed and the product was produced according to product specifications.All information reasonably known as of 12 mar 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that a nasogastric (ng) tube burst during use.The first half of the tube was retrieved easily but the second half required forceps to remove.Per additional information received 21 feb 2019, the tube piece was removed by an anesthetist using forceps without the aid of an endoscope.The tube had been in place around three months.There was a history of the tube clogging previously.The patient was an outpatient at the ward at the time of the incident.No further information provided.
Additional Manufacturer Narrative
One used sample was received for evaluation.The sample was in two pieces and was discolored.Under magnification, the tube showed signs of damage, and a split/tear was identified at the 47cm marking.The tubing appeared to have expanded/balloon at that point, prior to bursting axially.The distal end piece had evidence of dried, crusty material inside the tubing.The complaint is confirmed as reported.The root cause could not be conclusively determined, but is most likely use related.Per the instructions for use which accompany the device, 'syringe force should not be used to irrigate, administer liquids, or unblock the tube." all information reasonably known as of 12 apr 2019 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 halyard health 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: 8415146
• Report Number: 9611594-2019-00050
• Device Sequence Number: 16221493
• Product Code: KNT
• UDI-Device Identifier: 20815149020673
• UDI-Public: 20815149020673
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 04/01/2023
• Device Model Number: 42-9368
• Device Catalogue Number: 104609200
• Device Lot Number: 0202955176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/15/2019
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 54