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

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 28 jun 2021 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 Description

It was reported that the stylet was difficult to remove, causing puckering and small holes in the tube after removal.The stylet had been pre-tested to ensure free movement.The feeding tube was removed from the patient.No patient injury.

Manufacturer Narrative

Corrected: a2 patient age corrected from days to years.One used ng (nasogastric) tube was returned for evaluation.The stylet used in the reported event was not returned.The ng tube was infused with water, and tears/holes were noted along the tube.There were also areas of uneven/jagged/wrinkled surfaces along the tube.The tube was cut and the inside found to have lines and indentation along the inner walls.The complaint is confirmed as reported, and the root cause is most likely use related, as the event most likely occurred as a result of the user not flushing the tube prior to stylet removal, as described in the instructions for use.All information reasonably known as of 27 jul 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 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
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12083562
• MDR Text Key: 258952387
• Report Number: 9611594-2021-00089
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460925
• UDI-Public: 00350770460925
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-9368
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 32