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

Model Number	0250-16
Medical Device Problem Codes	Break (1069); Blocked Connection (2888)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.A root cause could not be determined.(b)(4) 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 (b)(4) 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 (b)(4) product is defective or caused serious injury.Device not returned.
Event or Problem Description
It was reported on 14-feb-2017 that a fda user facility report (b)(4) was received on 03-feb-2017 and the date of this report was 17-jan-2017.It was reported that a patient's transgastric jejunal tube was infusing tube feed all night.The kangaroo pump all alarmed clog in line.The nurse attempted to flush the line with toomey syringe and met a small amount of resistance.Pulsatile flushing was attempted and the side wall of line "popped" and the line was clamped off.Upon removal, the tube was found to be in the esophagus and both tube and balloon were severed.Additional information has been requested but not received yet.
Additional Manufacturer Narrative
Correction: manufacturing report number 9611594-2017-00506 was submitted to the fda incorrectly and 9611594-2017-00037 was the correct number.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).

• Common Device Name: DH EF PEG INITIAL PLACEMENT PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6382573
• Report Number: 9611594-2017-00506
• Device Sequence Number: 675922
• Product Code: KNT
• UDI-Device Identifier: 10680651954807
• UDI-Public: 10680651954807
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K921370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Model Number: 0250-16
• Device Catalogue Number: 991095480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR