MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.5 CM, 22 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	991095497
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for aa6193n19 was reviewed and the product was produced according to product specifications.All information reasonably known as of 11 dec 2017 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 the patient vomited milk on (b)(6) 2017.A contrast was performed and the gastric-jejunal tube was confirmed to be in the correct location, however, contrast was seen to leak from the tube close to the hub, indicating a leak into the stomach.No further information has been provided at this time.
Additional Manufacturer Narrative
One used sample was returned for evaluation.Visual inspection revealed that the molded head, tube, and balloon appeared to be discolored with foreign substances on the exterior and interior of the device.Feeding was simulated using water mixed with methylene blue through the jejunal feed port.There was an observance of water droplets exiting the gastric skives area.Feeding was simulated similarly through the gastric feed port and there was an observance of a leak in the gastric skives area.The gastric skives were examined under 30x magnification.The inner wall of the tubing which separates the jejunal and gastric lumens was torn approximately 8mm which allowed for an inner lumen communication.The molded head and strap were examined an did not exhibit any leakage.The balloon was infused with 5cc of water and there was no leakage observed.The manufacturing process was reviewed and nothing was found that could contribute to the reported malfunction.No root cause could be determined.All information reasonably known as of 31 jan 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
Per additional information received, a new tube inserted and the patient was discharged home.
Additional Manufacturer Narrative
All information reasonably known as of 04 jan 2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).

• Brand Name: MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.5 CM, 22 CM
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7109684
• Report Number: 9611594-2017-00167
• Device Sequence Number: 16371852
• Product Code: KNT
• UDI-Device Identifier: 10680651440843
• UDI-Public: 10680651440843
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2018

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: Other
• Device Expiration Date: 07/01/2018
• Device Model Number: 991095497
• Device Catalogue Number: 0270-16-1.5-22
• Device Lot Number: AA6193N19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 12/18/2017; 01/25/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/04/2018; 02/07/2018
• Patient Sequence Number: 1
• Patient Age: 3 YR