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

Model Number	20-9431
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nausea (1970); Pain (1994)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 25-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).
Event or Problem Description
It was reported that a patient with a digestive health tube (dht) which was placed on (b)(6) 2017 had the tube feeds and free water infusing.Overnight on (b)(6) 2017 the patient complained of epigastric pain, nausea, and shortness of breath.The tube feed pump also alarmed noting "clog downstream of pump" and tube was unable to be flushed.The physician was at the bedside to assess the patient and the nurse attempted to unclog dht with warm water.The physician ordered chest x-ray (cxr), abdominal x-ray (axr), electrocardiogram (ekg) and troponin lab values.The axr image showed that dht was in two separate pieces within the patient's abdomen.The physician immediately assessed the image and expedited reading and interpretation of the x-ray results from radiology, who confirmed that the tube was broken within the patient's abdomen.The physician contacted the gastrointestinal (gi) department for further instruction.The tube feeds were held per physicians order and patient nothing by mouth (npo) until further notice.Additional information received 04-aug-2017 stated both pieces of feeding tube were removed from the patient.It is unknown what procedure took place to remove tube.Current status of patient is unknown.No additional information was provided in regards to the patient's status and the outcome of the procedure.
Additional Manufacturer Narrative
The device history record for the reported lot number, 77680, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One device was returned.The device was placed across the table in a well-lit area.The device was in two pieces with an apparent separation of the device around the 31cm marking.The distal portion of the separated device was examined and manipulated to feel for the clogged area of the device.Once the location of the clog was identified, the tubing was cut around the 26cm marking the device had multiple locations with a foreign substance around the 30cm to 31cm marking, the tubing was reviewed and concluded that the tubing properties had expanded due to the clogging.The expanded area was viewed to see if there was any identification of the tubing tear/split origin.After manually putting the tubing together, it could not be determined where the tear started.All information reasonably known as of 20-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).

• Brand Name: HALYARD CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6823913
• Report Number: 3009124963-2017-00043
• Device Sequence Number: 1443930
• Product Code: KNT
• UDI-Device Identifier: 20815149023926
• UDI-Public: 20815149023926
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K821906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 20-9431
• Device Catalogue Number: 104579300
• Device Lot Number: 77680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/23/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR