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

Model Number	G29432
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
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.(b)(4).
Event or Problem Description
It was reported that the tip of the dilator from the melker emergency cuffed cricothyrotomy catheter set was found to be broken when the package was opened.The device was not used on the patient, and there were no injuries or additional procedures.

• 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: 7379463
• Report Number: 1820334-2018-00900
• Device Sequence Number: 1221092
• Product Code: JOH
• UDI-Device Identifier: 00827002294325
• UDI-Public: (01)00827002294325(17)180205(10)5634105
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1