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

Model Number 20-9366

Device Problems Burst Container or Vessel (1074); Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problems Laceration(s) (1946); Bowel Perforation (2668)

Event Date 10/19/2018

Event Type  Death  

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.Root cause could not be determined.All information reasonably known as of 22 oct 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).

Event Description

Fda medwatch / fda user facility report # mw5096539 received reporting the following information: "halyard 20-9366 6 french 36 inch burst/broke causing laceration to second portion of duodenum." the device was implanted (b)(6) 2018.

Manufacturer Narrative

Additional information: a1, a3, b2, b5, b6, e1, g3, h1, h6.All information reasonably known as of 17 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 inc.Complaint database and identified as complaint (b)(4)02816.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 Description

Additional information received 04-dec-2020 indicated that the patient's naso-duodenal tube fractured while it was in place on (b)(6) 2018.The patient suffered a bowel perforation at the site of the tube fracture and died in (b)(6) 2020.Exact date of death was not provided.

Event Description

Additional information received (b)(6) 2020 indicated that during surgical repair of the bowel, it was noted that the feeding tube was fractured but not broken in two; a slit was noted in the tube and remained in one piece.

Manufacturer Narrative

All information reasonably known as of 08 jan 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
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10719204
• MDR Text Key: 216659256
• Report Number: 9611594-2020-00206
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770457857
• UDI-Public: 00350770457857
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20-9366
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other