MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE; DH CORTRAK DISPOSABLES

Model Number	40-9368TRAK2
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Codes	Abdominal Distention (2601); No Code Available (3191)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.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
An fda medwatch report,(b)(4) was received stating, "event desc: a cortrak nasogastric jejunal tube (ngt) was inserted in a patient and placement was radiologically confirmed at the duodenal area.Pediatric surgery was consulted 5 days later for abdominal distention and suspicion for necrotizing entercolitis (nec).The patient subsequently underwent abdominal exploratory laparotomy the following day with findings jejunal perforation located at the distal tip of the nasogastric nj tube." additional information received 31-jan-2017 detailing age, weight ((b)(6)) and gender.

• Brand Name: CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6357784
• Report Number: 3009124963-2017-00004
• Device Sequence Number: 18938713
• Product Code: KNT
• UDI-Device Identifier: 20815149023865
• UDI-Public: 20815149023865
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

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?: Yes
• Operator of Device: Other
• Device Model Number: 40-9368TRAK2
• Device Catalogue Number: 104604401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 MO
• Patient Weight: 3