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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported while performing a procedure the blade of the catheter set broke.Additional information has been requested as of the date of this report no other information is available.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, instruction for use (ifu), manufacturing instructions, quality control, specifications, and trends 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 CRICOTHYROTOMY CATHETER SET
• Type of Device: BWC NEEDLE, EMERGENCY AIRWAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6089618
• MDR Text Key: 59563679
• Report Number: 1820334-2016-01254
• Device Sequence Number: 1
• Product Code: BWC
• UDI-Device Identifier: 00827002062467
• UDI-Public: (01)00827002062467(17)171126(10)5476953
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TCCS-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Date Device Manufactured: 11/26/2014
• 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): Required Intervention