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

Model Number	42-9558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 76937 was reviewed and the product was produced according to product specifications.All information reasonably known as of 17 apr 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).Device not returned.
Event or Problem Description
It was reported that the distal tip fell off.Per additional information received on (b)(6) 2018 the nasojejunal (nj) tube was inserted with radiological guidance on (b)(6) 2018.On (b)(6) 2018 the nursing staff noticed that the nj tube has migrated significantly, so it was removed.Upon removal it was noted that the distal tip was completely missing.The patient was observed for passage of the tip in the bowel movements.No harm to patient.
Additional Manufacturer Narrative
One used sample was returned for evaluation.The sample was received with no bolus tip attached.The bolus was not received.The distal end of the tubing was examined under magnification.The edge was smooth, with no jagged tearing.There are potential kerf marks visible on the end.The overall length of the returned sample measured 54 3/4 inches from the base of the y adaptor to the tip of the tubing.An assessment of the manufacturing process was performed, and no activities or tools that could cause this type of damage could be identified.The complaint is confirmed with unknown root cause.All information reasonably known as of 29 may 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).
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 10 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 WITH ENFIT CONNECTO
• Common Device Name: DH CORTRAK DISPOSABLES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7439520
• Report Number: 3011270181-2018-00009
• Device Sequence Number: 13704700
• Product Code: KNT
• UDI-Device Identifier: 20815149020727
• UDI-Public: 20815149020727
• 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,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2018

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 Expiration Date: 01/31/2022
• Device Model Number: 42-9558
• Device Catalogue Number: 104609900
• Device Lot Number: 76937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/22/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/14/2018; 05/31/2018
• Patient Sequence Number: 1