MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS; DH EF BALLOON TUBES PRODUCTS

Model Number	8270-16-1.5-30
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A dhr review of lot aa7345n37 is in progress.All information reasonably known as of 13 aug 2018 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 halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that there was a hole in the jejunal lumen behind the balloon.No further information has been provided.
Event or Problem Description
Per additional information received 20 aug 2018, the jejunum lumen had a hole in it just below the balloon, so the feed was entering the stomach instead of the jejunum.There was no injury to the patient, and "everything is fine and good with the patient.".
Additional Manufacturer Narrative
One used sample was returned for evaluation.The molded head, tube, and balloon were discolored with a foreign substance and the sample had a strong odor.During decontamination of the sample, most of the foreign material build up inside the jejunal lumen was flushed out of the tube.The balloon was filled with water and no leaks were observed.Feeding was simulated with water through the jejunal feed port.Droplets were observed exiting the gastric skives area.Feeding was simulated through the gastric feed port, and liquid was observed inside the jejunal lumen.The gastric skives were examined under 40x magnification, and the inner wall of the tubing that separates the jejunal and gastric lumens had a tear approximately 6.5cm, which allowed for an inner lumen crossover.The tear was jagged in appearance.The complaint was confirmed as reported.A review of the manufacturing process did not reveal any activities or tools that could have caused this type of damage to the inner lumen.No root cause could be determined.The device history record for lot aa7345n37 was reviewed and the product was produced according to product specifications.All information reasonably known as of 14 sep 2018 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 halyard health complaint database and identified as complaint (b)(4).

• Brand Name: MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT EXTENSION SETS
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7777859
• Report Number: 9611594-2018-00111
• Device Sequence Number: 1204596
• Product Code: KNT
• UDI-Device Identifier: 10680651440850
• UDI-Public: 10680651440850
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 8270-16-1.5-30
• Device Catalogue Number: 104408500
• Device Lot Number: AA7345N37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 09/17/2018
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 13