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

Model Number	42-9368
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2017
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 not possible as no lot number was provided.Root cause could not be determined.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 comp (b)(4).
Event or Problem Description
A report was received from (b)(6) stating, "we have had another problem with a tube." a new ngt had a hole in the main body of the tube and had to be removed.Additional information received (b)(6) 2017 stated, "the tube had been inserted and the staff were trying to get an aspirate and were unsuccessful.When they pulled the tube out that is when they noticed that it had a hole." no additional information was provided.

• Brand Name: 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: 6407226
• Report Number: 3009124963-2017-00006
• Device Sequence Number: 797616
• Product Code: KNT
• UDI-Device Identifier: 20815149020673
• UDI-Public: 20815149020673
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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: Other Health Care Professional
• Device Model Number: 42-9368
• Device Catalogue Number: 104609200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/15/2017
• Patient Sequence Number: 1