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

Model Number	20-9431TRAK2
Medical Device Problem Codes	Break (1069); Disconnection (1171); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 17-aug-2017 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).Device not returned.
Event or Problem Description
A halyard health maude database reconciliation was performed on 25-jul-2017 and identified maude report number (b)(4) as not in halyard health's internal systems.The report stated: "on a routine chest x-ray, the tube was noted to be disconnected inside of the pt., noted as a "fracture." a following ct revealed that the feeding tube had fractured and that the distal portion of the tube had migrated into the small bowel." no further information was received.
Additional Manufacturer Narrative
The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 03-oct-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be 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).

• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6804180
• Report Number: 3009124963-2017-00042
• Device Sequence Number: 11032876
• Product Code: KNT
• UDI-Device Identifier: 20815149023940
• UDI-Public: 20815149023940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 20-9431TRAK2
• Device Catalogue Number: 104579700
• Device Lot Number: 73292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 10/17/2017
• Patient Sequence Number: 1