MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 2.7 CM, 45 CM; DH EF BALLOON TUBES PRODUCTS

Model Number	0270-16-2.7-45
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was 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).Device not returned.
Event or Problem Description
It was reported that the mic-key jejunal feeding tube port was feeding into the patient's stomach.Because of the patient's condition, this could cause to patient to become very sick.No further information has been provided at this time.
Additional Manufacturer Narrative
One used device was received for evaluation.The feed pathway of the sample was visually inspected.At the forth gastric skive, a breach of the inner septum was observed.This would allow the jejunal feeding to enter the gastric feed lumen and exit the gastric skives.A small cut or tear was also noted at the distal end of the forth skive.The manufacturing process was reviewed, and nothing was found that could cause this type of damaged to the device.No root cause could be identified.The device history record for (b)(4) was reviewed and the product was produced according to product specifications.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, the hospital alleges the mic key was placed correctly, however when contrast was injected under xray via the jejunal port, it showed that the contrast was going into the stomach, even though the tip of the tube was in the jejunum.

• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6267357
• Report Number: 9611594-2017-00015
• Device Sequence Number: 82603
• Product Code: KNT
• UDI-Device Identifier: 10680651956474
• UDI-Public: 10680651956474
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K926581
• 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
• Report Date (Section B): 03/16/2017

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: Other
• Device Expiration Date: 09/01/2017
• Device Model Number: 0270-16-2.7-45
• Device Catalogue Number: 991095647
• Device Lot Number: AA5257N19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 03/30/2017
• Patient Sequence Number: 1