MAUDE Adverse Event Report: COOK INC MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET; BWC NEEDLE, EMERGENCY AIRWAY

Model Number	G29432
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(6), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that while the melker emergency cuffed cricothyrotomy catheter set was being used, the plastic part of the catheter introducer needle kinked, and the wire guide could not get through it.The procedure was successfully completed with a bronchoscope, and there were no injuries or additional procedures.

• Brand Name: MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET
• Common Device Name: BWC NEEDLE, EMERGENCY AIRWAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7374733
• Report Number: 1820334-2018-00875
• Device Sequence Number: 1426574
• Product Code: BWC
• UDI-Device Identifier: 00827002294325
• UDI-Public: (01)00827002294325(17)180223(10)5670385
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: Health Professional
• Device Model Number: G29432
• Device Catalogue Number: C-TCCSB-500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60