MAUDE Adverse Event Report: HALYARD HEALTH CPK CORFLO W/ STYLET - U LITE ENFIT NG; DH CPK NG TUBES

Model Number	42-9366
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: the actual device was not returned.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.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.All information reasonably known as of 21-apr-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 (b)(4).Device not returned.
Event or Problem Description
Halyard received a single report that referenced three different incidents, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 3009124963-2017-00015 for the second patient.Refer to 3009124963-2017-00016 for the third patient.It was reported that a patient experienced an nj tube that deteriorated.It was picked up on x-ray that the nj tube split at the top of the tube near the patient's trachea.The patient was required to go to the operating room to have the tube removed.No further information was received.

• Brand Name: CPK CORFLO W/ STYLET - U LITE ENFIT NG
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6512719
• Report Number: 3009124963-2017-00014
• Device Sequence Number: 18924725
• Product Code: KNT
• UDI-Device Identifier: 20815149020666
• UDI-Public: 20815149020666
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2017

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: 10/31/2021
• Device Model Number: 42-9366
• Device Catalogue Number: 104609100
• Device Lot Number: 76020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/21/2017
• Patient Sequence Number: 1