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

Model Number	41-1368
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Pneumothorax (2012)
Date of Event	05/31/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 25-jul-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).Device not returned.
Event or Problem Description
Halyard received a single report from the (b)(6), stating "a corflow nasogastric tube was sited tor feeding purposes on (b)(6) 2017.On the subsequent check chest x-ray, it was noted to lie in the right lung and a right apical pneumothorax was also noted.There had been no pneumothorax on previous chest x-rays and the patient had not shown clinical signs of a pneumothorax.Our impression was that the ng tube had caused a lung injury resulting in the development of the pneumothorax.Small volume right pneumothorax, managed conservatively to good effect.At time: ng tube removed immediately unfortunately disposed of by ward staff prior to escalation of incident), respiratory opinion sought." additional information received 14-jul-2017 stated, " the death of the patient was (b)(6) 2017, the cause of death was (as per death certificate) aspiration pneumonia, severe vascular dementia, hypertension, type-2 diabetes mellitus, cerebral vascular accident and parkinsonism.
Additional Manufacturer Narrative
The investigation concluded that the root cause of the reported issue was determined to be incorrect use of the device.All information reasonably known as of 2-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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: HALYARD CORFLO NASOGASTRIC/NASOINTESTINAL NEONATAL FEEDING TUBE WITH ENFIT
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6750102
• Report Number: 3009124963-2017-00036
• Device Sequence Number: 882017
• Product Code: KNT
• UDI-Device Identifier: 20815149021281
• UDI-Public: 20815149021281
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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?: No
• Operator of Device: Other Health Care Professional
• Device Model Number: 41-1368
• Device Catalogue Number: 104606900
• Device Lot Number: ANP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR