MAUDE Adverse Event Report: HALYARD HEALTH HALYARD CORFLO NASOGASTRIC/NASOINTESTINAL NEONATAL FEEDING TUBE WITH ENFIT CO; 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); Perforation (2001); Pneumothorax (2012)
Date of Event	05/27/2017
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).
Event or Problem Description
Halyard received a single report from the (b)(6), stating a corflow nasogastric tube was inserted into a patient for feeding purposes following a episode of aspiration.On post insertion chest x-ray a large left pneumothorax was noted, with the nasogastric tube following the trachea, deviating into the left main bronchus at the carina.The tip of the tube was noted in the left diaphragmatic sulcus, appearing to lie outside of the boundaries of the left lung.Our impression was that the nasogastric tube (ng) tube had been inserted erroneously into the trachea and had tracked into the left lung via the left main bronchus.It had then perforated through the lung parenchyma and caused a lung injury resulting in the pneumothorax.The patient sustained a pneumothorax requiring chest drain insertion.The pneumothorax resolved following drain insertion but the patient died on (b)(6) 2017.The ng was tube removed immediately on diagnosis of pneumothorax and patient referred to respiratory team who inserted a chest drain to good effect.Additional information received 14-jul-2017 stated, the patient died (b)(6) 2017, cause of death (as per the certificate) pneumonia, cerebral vascular accident (cva), atrial fibrillation, hypertension, ischemic heart disease, congestive heart failure.
Additional Manufacturer Narrative
All information reasonably known as of 11-aug-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).
Event or Problem Description
Additional information received 8-aug-2017 stated: patient information: (b)(6) kg, age (b)(6), female (patient information updated accordingly) according to the physician¿s opinion, what is the cause of the patient¿s death? cause of death was cerebral infarct (stroke) complicated by pneumonia and acute kidney injury (renal failure).
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 CO
• Common Device Name: DH CPK NG TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6750103
• Report Number: 3009124963-2017-00035
• Device Sequence Number: 1095721
• 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,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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 08/08/2017; 09/07/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/25/2017; 10/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 66