MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 14 FR, 2.0 CM - 30 - NON-ENFIT; DH EF BALLOON TUBES PRODUCTS

Model Number 0270-14-2.0-30

Device Problem Fluid/Blood Leak (1250)

Patient Problem Vomiting (2144)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned, and is being processed for evaluation.The device history record for lot 30039081 was reviewed, and the product was produced according to product specifications.All information reasonably known as of 16 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that there was a leak of the tube into the patient's duodenal region from the gastric lumen.The patient had a recently replacement of the gastro-jejunal (gj) tube and had been vomiting.A contrast study was performed as follows: "the patient was placed in the right side down decubitus position and the extension tubing connected to the gastric port.Contrast was injected, but did not fill the stomach.Contrast promptly filled the duodenum.Appropriate connection of the tubing to the gastric port was confirmed with the technologist.The patient was then turned supine.Contrast was again seen in the duodenum, more so proximally.The tube was flushed with sterile water.Extension tubing was attached to the j port of the existing gastrojejunostomy tube.Contrast injection demonstrates contrast coming from the distal tube filling the duodeno-jejunal junction , as expected.".

Manufacturer Narrative

One used feeding tube was returned for evaluation.The feeding tube exhibited some discoloration, though visual inspection of the tube and both ports revealed no obvious damage to the device.Both the gastric and jejunal ports were tested using syringes filled with colored liquid and no leakage was observed.Fluid injected into the gastric port exited via the gastric skives, and fluid injected into the jujunal port exited from the jejunal skives.The reported event could not be replicated.The event cannot be confirmed as reported.No root cause identified.All information reasonably known as of 03 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 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-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 14 FR, 2.0 CM - 30 - NON-ENFIT
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10713208
• MDR Text Key: 214396625
• Report Number: 9611594-2020-00202
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770472331
• UDI-Public: 00350770472331
• Combination Product (y/n): N
• PMA/PMN Number: K922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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 Expiration Date: 02/01/2022
• Device Model Number: 0270-14-2.0-30
• Device Catalogue Number: N/A
• Device Lot Number: 30039081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/05/2020
• Patient Sequence Number: 1
• Patient Age: 8 YR