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

Model Number 40-7438

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 0020003750 was reviewed, and the product was produced according to product specifications.All information reasonably known as of (b)(6) 2020, has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.This product incident is documented in the avanos medical complaint database, and identified as complaint (b)(4).

Event Description

Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving an unknown number of patients.This is the third of three reports.Refer to 9611594-2020-00174 for the first report.Refer to 9611594-2020-00175 for the second report.It was reported that during placement, the doctor had difficulty removing the stylet from the nasogastric (ng) tube.Upon removal, the ng tube had holes in it.Per additional information received on 02 sep 2020, attempting removal of the stylets resulted in deterioration of the ng tube, and led to holes.No further information provided.

• 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
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10514046
• MDR Text Key: 211687628
• Report Number: 9611594-2020-00176
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460345
• UDI-Public: 00350770460345
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-7438
• Device Catalogue Number: N/A
• Device Lot Number: 0020003750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1