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

Catalog Number C-TCCSB-500-SPOPS

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Death (1802)

Event Type  Death  

Event Description

During a cricothyrotomy on a large (overweight) pt, the included disposable scalpel was too small to cut through all of the tissue in order to create an airway.The pt expired.The user facility is not claiming the device is at fault for the pt outcome.However, it was recommended that a larger scalpel be included, to accommodate all type of pts.

Manufacturer Narrative

Date of death unk.Device code - it appears there was nothing wrong with the supplied scalpel but that it was not long enough to see on an obese pt.No mention of pt size in the ifu.Event evaluation: still under investigation.

• Brand Name: MELKER EMERGENCY CUFFED SPECIAL OPERATIONS CRICOTHYROTOY CATHETER SET
• Type of Device: BWC NEEDLE, EMERGENCY AIRWAY
• Manufacturer (Section D): COOK INC; bloomington IN 47402
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3999532
• MDR Text Key: 4690198
• Report Number: 1820334-2014-00350
• Device Sequence Number: 1
• Product Code: BWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-TCCSB-500-SPOPS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death