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

Model Number	20-9225
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code-no code available/lung placement.The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.Upon completion of the sample evaluation and the investigation; a follow-up report will be filed.All information reasonably known as of 27-oct-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.(b)(4).
Event or Problem Description
It was reported that a 5-french nasoduodenal (nd) tube placement was attempted on the patient.A kidneys urethra and bladder (kub) radiology exam revealed that the tube was in the patient's lung and not in the nd area of the gastrointestinal tract.The tube was removed.After removal of the tube it was noted that the stylet had perforated the tube.The incident was reported to the charge nurse.Additional information was received 20-oct-2017 and stated the package was opened and the tube was flushed.The stylet was easily removable.The stylet was not removed prior to insertion of the device.The nasogastric (ng) tube was inserted.An x-ray showed that the tube was not in the ng area of the digestive tract.The tube was removed in an effort to attempt better placement.When the tube was completely removed, it was noted that the stylet had perforated the ng tube.There was no harm reported to the patient.No additional information was provided.
Additional Manufacturer Narrative
One used sample was received that was not returned with the original packaging.The returned sample device was examined, it was noted that the tubing had signs of bending and kinking.The stylet was still inside the ng tube, while attempting to remove the stylet it did not remove easily.The nasogastric (ng) tube was then flushed on the side port with water.Once more an attempt was performed to remove the stylet, the removal was successful after the water flush.The stylet exhibited bending and kinking in multiple areas.There was an external dent mark identified after the ng tube sample was inspected under magnification.It was noted at approximately 3.5 cm from the dent mark identified until the end, just before the bolus tip.The tubing was cut on the area with the dent mark to view the inside surface of the tubing.Once the tubing was opened, there was an indentation in the inner wall of the tubing.The root cause was attributed to user-related.The incident report confirmed that the tube was not placed correctly.It is unknown how the feeding tube may have caused or contributed to the reported event.Similar holes and kinks in the tubing have been seen when failing to irrigate the tube before removing the stylet.All information reasonably known as of 13-feb-2018 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: 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: 6984353
• Report Number: 3009124963-2017-00051
• Device Sequence Number: 13577610
• Product Code: KNT
• UDI-Device Identifier: 10815149023745
• UDI-Public: 10815149023745
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: Nurse
• Device Model Number: 20-9225
• Device Catalogue Number: 104577100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 02/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO