MAUDE Adverse Event Report: HALYARD HEALTH HALYARD CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING; DH CPK NG TUBES

Model Number	42-7368
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is reported to be available but has not yet been returned.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 05-jul-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).
Event or Problem Description
A report was received stating the size-10 nasogastric tube (ngt) burst during flushing of the device with a 5ml ngt syringe.The doctor removed the remaining half of the device from inside of the patient's mouth.No additional information was provided in regards to the patient's status.
Additional Manufacturer Narrative
The device history record for the reported lot number, 74300, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements all information reasonably known as of 05-sep-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).

• Brand Name: HALYARD CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6696798
• Report Number: 3009124963-2017-00032
• Device Sequence Number: 19349320
• Product Code: KNT
• UDI-Device Identifier: 10815149020560
• UDI-Public: 10815149020560
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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: Physician
• Device Expiration Date: 04/30/2021
• Device Model Number: 42-7368
• Device Catalogue Number: 104608200
• Device Lot Number: 74300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 09/08/2017
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 96