MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN CORFLO 10FR NASOGASTRIC TUBE; DH CPK NG TUBES

Model Number	UNKNOWN
Medical Device Problem Codes	Complete Blockage (1094); Fracture (1260)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 09 nov 2020 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 avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that, after flushing the nasogastric (ng) tube with 20ml water to remove a blockage, water began coming out of the patient's mouth.The patient then began to vomit, and the ng tube came out of the patient's mouth, broken.The ng tube was removed from the patient in two parts.The tube had been placed on (b)(6) 2020.No further information provided.
Additional Manufacturer Narrative
Correction: per review of the information provided by the customer, the product information has been changed to unknown 10fr corflo nasogastric tube.All information reasonably known as of 11 dec 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: UNKNOWN CORFLO 10FR NASOGASTRIC TUBE
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10813360
• Report Number: 9611594-2020-00216
• Device Sequence Number: 16981500
• Product Code: KNT
• UDI-Device Identifier: 00350770458304
• UDI-Public: 00350770458304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNKNOWN
• 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): 12/11/2020

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 Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/12/2020
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 68