MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NG/NI FEED TUBE, STYLET WITH ENFIT; DH CPK NG TUBES

Model Number 40-9551

Device Problems Difficult to Remove (1528); Stretched (1601); Obstruction of Flow (2423)

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

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 06-feb-2024 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 feeding tube in place approximately 3 weeks; it was being removed when patient reported tube 'felt stuck' and it was difficult for staff to pull.Patient was taken to radiology for gi to remove; was noted that tube had 'aneurysm in the distal portion of the tube." there was no reported injury.Additional information received 17-jan-2024 stating the "patient was unable to flush tube that had been in use for 3 weeks.When the tube was removed for replacement, a bulge was noted in the distal portion.No patient injury, the feeding tube had to be replaced via fluoroscopy guidance." the lot number could not be confirmed.

• Brand Name: CORFLO NG/NI FEED TUBE, STYLET WITH ENFIT
• 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: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18655620
• MDR Text Key: 334805496
• Report Number: 9611594-2024-00013
• Device Sequence Number: 1
• Product Code: KNT
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9551
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1