MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR - ENDOSCOPIC/RADIOLOGI; DH EF BALLOON TUBES PRODUCTS

Model Number 8650-16

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.Photos of the device were provided by the distributor.All information reasonably known as of 02 oct 2020 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 inc.Complaint database and identified as complaint (b)(4).Device not returned; photos provided.

Event Description

It was reported that there is a, "hole in the tube just under feed ports.Also 1 month reports of meds [medication] given via jej, jejunal port, appearing in gastric tube, and gastric drainage bag." no patient injury was reported.Additional information received 21-sep-2020 indicated the feeding tube was replaced in interventional radiology.There was no harm to the patient.Additional information received 24-sep-2020 in the form of an evaluation report from the distributor indicated the product was in use for approximately 5 months.The balloon was inflated using 10ml of cooled, boiled water.According to the distributor, no obvious signs of molding deformity or manufacturing material weakness were identified.No sign of a leak from the jejunal lumen into the gastric lumen was identified.A tear was identified at the connection between the tubing section, and the feed port section of the device.

Manufacturer Narrative

The device history record for lot aa8295n09 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Photos of the device were provided by the distributor and the reported incident was confirmed.However, root cause could not be determined.All information reasonably known as of 09 nov 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).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: MIC GASTRIC-JEJUNAL FEEDING TUBE KIT WITH ENFIT CONNECTOR - ENDOSCOPIC/RADIOLOGI
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10648286
• MDR Text Key: 210421381
• Report Number: 9611594-2020-00189
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770445731
• UDI-Public: 00350770445731
• Combination Product (y/n): N
• PMA/PMN Number: K921370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 8650-16
• Device Catalogue Number: N/A
• Device Lot Number: AA8295N09
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Patient Sequence Number: 1