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

Model Number 42-9361

Device Problem Stretched (1601)

Patient Problems Airway Obstruction (1699); Discomfort (2330)

Event Date 05/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot 0001003703 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.The customer provided a photo of the device.The root cause could not be conclusively determined.However, it seems to be a use related problem since as per the ifu, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of (b)(6) 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.

Event Description

It was reported the patient had a panic attack and felt like he could not breathe following administration of medication through the ng [nasogastric] tube.The patient went to daycare in the afternoon and explained how he felt like he could not breathe and his throat felt funny.The ng tube was removed on (b)(6) 2021 as it was no longer required for magnesium and calcium supplements, and the ng tube was found to have an "air bubble." according to the customer, the "bubble" would have sat in the patient's throat.Additional information received 25-may-2021 indicated "patient complained of feeling blockage in throat when medications administered at home.Ng tube no longer required when attended hospital for routine appointment and therefore removed.On removal it became apparent that a section of the tube was distorted, as if it had inflated.Patient distress when medications delivered, felt unable to breathe.".

• 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: 11959015
• MDR Text Key: 268506497
• Report Number: 9611594-2021-00080
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460888
• UDI-Public: 00350770460888
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2021

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: Lay User/Patient
• Device Model Number: 42-9361
• Device Catalogue Number: N/A
• Device Lot Number: 0001003703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 44