MAUDE Adverse Event Report: COOK INC MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Death (1802); No Code Available (3191)
Date of Event	02/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The customer reported that oxygen could be delivered to the patient through the melker emergency cuffed cricothyrotomy catheter, but it could not be removed through the device.The aperture of the catheter was reportedly so small that ventilation could not be achieved, although oxygenation did occur because the air could be forced in.Auto-peep (positive end expiratory pressure) resultantly developed.The patient was taken back to the or to exchange the device emergently for a trach, but ultimately the patient expired.The manufacturer global product manager has attempted to gain additional information on 16mar2018 and was redirected to the user facility risk management department.The manufacturer global product manager was able to speak with the nurse present for the procedure on 19mar2018, she did not provide additional information but has indicated she would have the physician return the manufacturer's call.The customer has indicated that they are unwilling to provide patient-related information.The device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7362896
• Report Number: 1820334-2018-00770
• Device Sequence Number: 1051730
• Product Code: JOH
• UDI-Device Identifier: 00827002304888
• UDI-Public: (01)00827002304888(17)201102(10)8340945
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K010016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TCCSB-500-SUR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death