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

Model Number	G04652
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that the scalpel provided in the melker emergency cricothyrotomy catheter set was dull and unusable.This product problem occurred twice, but it did not result in any reported adverse effects to the patients.

• Brand Name: MELKER EMERGENCY 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: 7374280
• Report Number: 1820334-2018-00886
• Device Sequence Number: 1273592
• Product Code: JOH
• UDI-Device Identifier: 00827002046528
• UDI-Public: (01)00827002046528(17)160601(10)4351508
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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: G04652
• Device Catalogue Number: C-TCCS-600
• 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