MAUDE Adverse Event Report: HALYARD HEALTH CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ANTI-IVCONNECTOR; DH CPK ANTI-IV (AIV) FEEDING TUBES

Model Number	20-9225AIV2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 12-jul-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).
Event or Problem Description
It was reported the tip of the nasogastric (ng) tube broke off and was inside the patient.There was no reported injuries.Additional information received 29-jun-2018 stated a 5fr corpak ng was placed without stylet (our procedure is to not use the stylet when placing corpak in infants) (b)(6) 2018.On (b)(6) 2018, an x ray was performed due to respiratory distress.The tip of the device was seen separated on x-ray.The tube in place was removed and the tip was not on the tube.The tube appeared to be severed with a very clear cut where the wider part (tip) connected to the narrower part of the ng.The patient excreted the tip of the device on (b)(6) 2018.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
One sample device was returned.The original packaging was not received with the device.It appeared that the tip of the nasogastric (ng) tube was separated from the entire tubing.There was sign of a bonding agent residue on one side of the tube while no visible residue on the other side when the tube was turned on the opposite way.There were no damages, jagged appearances on both ends (separation end) of the tube and bolus plug noticed.Inside the bolus plug there was light brownish dried material build up observed.The root cause was due to a weak bond.All information reasonably known as of 04-oct-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).

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ANTI-IVCONNECTOR
• Common Device Name: DH CPK ANTI-IV (AIV) FEEDING TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7695128
• Report Number: 3011270181-2018-00024
• Device Sequence Number: 1269610
• Product Code: FPD
• UDI-Device Identifier: 10815149023752
• UDI-Public: 10815149023752
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: Other
• Device Model Number: 20-9225AIV2
• Device Catalogue Number: 104577200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/04/2018
• Patient Sequence Number: 1
• Patient Age: 2 MO