MAUDE Adverse Event Report: HALYARD HEALTH CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET AND ENFIT CONNECTOR; DH CORTRAK DISPOSABLES

Model Number	40-9368
Medical Device Problem Codes	Burst Container or Vessel (1074); Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 23 feb 2018 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 the device developed a clog and then burst.Per the report, when the nurse assessed the nasojejunal tube at 0800, it was noted to have slight resistance when pushing air for auscultation.However, the tube had adequate syringe snapback.The nurse attempted to give water prior to administration of medicine at 0930, but the water back-flowed into the syringe.Pulsating water back into the tube with the syringe was not successful.The nurse retracted the tube 5 cm, and reattempted water administration with no success.The patient's father reported to the nurse that the previous dayshift nurse had difficulty flushing medications and that the feeding tube rang "no flow" often.There were no issues reported overnight.The nurse used coke to attempt to de-clog the tube, however, when the coke was inserted, a loud pop was heard, and coke began coming out of the patient's nose.The tube was immediately removed, and a large hole was found at the 49.5 cm mark.There was no injury to the patient.No further information has been provided at this time.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 04apr2018 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).
Additional Manufacturer Narrative
One used sample was received.No product packaging was received.The product did not contain a lot number identification.The sample was received with a neomed neoconnect 12ml enfit syringe attached to the side port.During decontamination, no occlusion or resistance was experienced when flushing the solution through the proximal section of the tube.However, occlusion was found in the distal section of the tube, from the point of the rupture.The tubing exhibited a rupture between the 49cm and 50cm markers.The tube wall has "ballooned" or stretched.The two sections of tubing remained attached on one side.Approximately at the 47cm marker, the tubing was crimped.This was distal of the rupture.The interior of the tubing was examined, at the point of rupture.In the proximal section, no occlusion or dried matter was observed.In the distal section, lumpy matter was observe in the tubing.The build-up of matter appeared to be located between the rupture and the crimp below it.The root cause could not be determined; however the tubing exhibited "ballooning" with complete rupture at the 47cm mark.Furthermore, this seems to be a user related problem, vigorous syringe force should not be used to irrigate, administer liquids or unblock the tube.All information reasonably known as of 18-may-2018 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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET AND ENFIT CONNECTOR
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7300189
• Report Number: 3011270181-2018-00001
• Device Sequence Number: 1424262
• Product Code: KNT
• UDI-Device Identifier: 10815149020416
• UDI-Public: 10815149020416
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2018

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: Nurse
• Device Model Number: 40-9368
• Device Catalogue Number: 104604300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/16/2018; 04/23/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/04/2018; 05/21/2018
• Patient Sequence Number: 1