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

Model Number 40-7431

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 22 apr 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

It was reported that the device was "placed on (b)(6) 2020, ruptured on (b)(6) 2020.Tube noted to be clogged on (b)(6) 2020, attempted clog zapper with no improvement, kub [kidney, ureter, bladder x-ray] showed kink, pulled back tube 2 cm, clog zapper again, then flushed, (b)(6) 2020 pink coloring of ett [endotracheal tube] secretions which matched meds prev.Given via tube." "kub findings: likely small kink in the region the proximal gastric portion of the enteric tube." "(b)(6) 2020 unchanged feeding tube opening at distal duodenum with kink in gastric portion of tubing." "(b)(6) 2020 continued focal kinking in the proximal gastric portion of the enteric tube." patient was not reported to be injured.Additional information received on 02-apr-2020 indicated "a kink at the 25cm marking-also the tube displays a break above the site of the kink- it is in two pieces-the distal portion was retrieved via endoscopy on (b)(6) 2020." no adverse effects were reported.Customer reported that "tube in for greater than 30 day and that staff may have used force in an attempt to de-clog.".

• 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: 9990407
• MDR Text Key: 189369516
• Report Number: 9611594-2020-00070
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651460322
• UDI-Public: 10680651460322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2020

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
• Device Operator: Health Professional
• Device Model Number: 40-7431
• Device Catalogue Number: 104603200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 23