MAUDE Adverse Event Report: HALYARD HEALTH MIC* TJ FEEDING TUBE KIT 16 FR, 45CM (ENDO/RADIOL); DH ENTERAL FEEDING BALLOON TUBE PRODUCTS

Model Number	0250-16
Medical Device Problem Code	Coiled (1098)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation.The device history record (dhr) for the lot number, aa7058n14, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.There were no abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Root cause could be determined.All information reasonably known as of 21jun2017 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.(b)(4).
Event or Problem Description
It was reported that a patient was experiencing symptoms for the past four to five days.The patient was sent to have an x-ray of the intestinal tubing for a possible clog or to see if the tubing had moved.No further information was provided.Additional information was received 25-may-2017 that stated that the patient was admitted to the icu on (b)(6) 2017.The tubing was determined to be mic peg and j tubing.The tube was placed between 10 days and four weeks ago, by the physician in the interventional radiology department.There were no reported injuries.On 02-jun-2017, additional information was received reporting the tube was observed on x-ray to be coiled in the stomach and was confirmed by the physician.No additional information was provided.

• Common Device Name: DH ENTERAL FEEDING BALLOON TUBE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6663458
• Report Number: 9611594-2017-00092
• Device Sequence Number: 11255953
• Product Code: KNT
• UDI-Device Identifier: 10680651954814
• UDI-Public: 10680651954814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K921370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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: Physician
• Device Expiration Date: 03/01/2018
• Device Model Number: 0250-16
• Device Catalogue Number: 991095480
• Device Lot Number: AA7058N14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/23/2017
• Patient Sequence Number: 1