MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY CONTINUOUS FEED EXTENSION KIT; ENTERAL FEEDING ACCESSORIES

Model Number	0141-12
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.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.(b)(4).
Event or Problem Description
It was reported by the patient's mother that the cap on the device came open and the formula leaked out.The patient was normally on an overnight continuous feed, but on the day of the event, the mother had put the patient on a daytime continuous feed.The mother left the room and, upon returning at one point, found the formula leaking out of the second port of the device, which had come uncapped.The mother reset the feed for the full amount again, without incident.The mother alleges that the patient's condition, which was not disclosed, makes it dangerous for the patient to go without the formula.No further information has been provided at this time.
Additional Manufacturer Narrative
Patient weight was provided in report.

• Brand Name: MIC-KEY CONTINUOUS FEED EXTENSION KIT
• Common Device Name: ENTERAL FEEDING ACCESSORIES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6175136
• Report Number: 9611594-2016-00184
• Device Sequence Number: 929138
• Product Code: KNT
• UDI-Device Identifier: 30680651441813
• UDI-Public: 30680651441813
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017

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 Model Number: 0141-12
• Device Catalogue Number: 104418100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 02/14/2017
• Patient Sequence Number: 1
• Patient Weight: 11