MAUDE Adverse Event Report: HALYARD HEALTH CORTRAK* 2 NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMIT; DH CORTRAK DISPOSABLES

Model Number	42-9551TRAK2
Medical Device Problem Codes	Occlusion Within Device (1423); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2018
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 in-progress.All information reasonably known as of 31-jan-2018 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 the patient had a naso-jejunostomy (nj) tube and complained of the tube being blocked and feeling uncomfortable.Upon removal of tube for replacement, the device had a burst like appearance approximately at the 70-75 cm mark.The nj tube was located at the 105 cm mark in the nare and had been in use for a month.The were no injuries or medical intervention reported.No additional information was provided.
Additional Manufacturer Narrative
The device history record for the reported lot number, 74029, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 27-jun-2018 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7233697
• Report Number: 3009124963-2018-00005
• Device Sequence Number: 1994153
• Product Code: KNT
• UDI-Device Identifier: 10815149020980
• UDI-Public: 10815149020980
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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 Health Care Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 42-9551TRAK2
• Device Catalogue Number: 104609800
• Device Lot Number: 74029
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 06/28/2018
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 41