MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 2.0 CM, 30 CM; DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number	0270-16-2.0-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned when this report was filed.The device history record for the lot number, aa6340n16, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 10apr2017 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).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 a halyard health product is defective or caused serious injury.
Event or Problem Description
It was reported that a transgastric-jejunal feeding tube broke at the adapter and fell into the patient's gastro-intestinal tract.This required the patient to have an additional procedure to remove the tube which included 15-minutes of fluoroscopy time.No additional information was provided.
Additional Manufacturer Narrative
Halyard health received one used sample with the molded head separated from the tubing.No product packaging was received.Attached to the feed ports were amt brand extension sets.The tubing exhibited brown buildup throughout.This remained after decontamination.The tubing was severed from the base of the molded head.The edges were examined under magnification and appeared relatively smooth, with no jagged tearing observed.The buildup inside was similar in appearance to a fungal or yeast attack on the silicone.The sample provided was evaluated and confirmed the tearing effect at the bonded location.However, there were no found activities or tools that could cause this type of flaw in the tube component.The root cause for this incident could not be conclusively determined.All information reasonably known as of 28-sep-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).

• Common Device Name: DIGESTHEALTH ENTERAL FEED TUBE KITS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6501393
• Report Number: 9611594-2017-00065
• Device Sequence Number: 1458100
• Product Code: KNT
• UDI-Device Identifier: 10680651956405
• UDI-Public: 10680651956405
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K922667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: Radiologic Technologist
• Device Expiration Date: 12/01/2018
• Device Model Number: 0270-16-2.0-30
• Device Catalogue Number: 991095640
• Device Lot Number: AA6340N16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 04/18/2017
• Supplement Report FDA Received Date: 09/28/2018
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 25