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

Model Number	G07546
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2016
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.
Event or Problem Description
It was reported that when the user picked up the syringe from the melker emergency cricothyrotomy catheter set after opening the package, they found the plunger of the proximal end was broken.They replaced it with another one from their stock, and the device did not make patient contact.There were no injuries or additional procedures.

• Brand Name: MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
• Common Device Name: BWC NEEDLE, EMERGENCY AIRWAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7378796
• Report Number: 1820334-2018-00897
• Device Sequence Number: 1252796
• Product Code: BWC
• UDI-Device Identifier: 00827002075467
• UDI-Public: (01)00827002075467(17)181013(10)6192486
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• 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: G07546
• Device Catalogue Number: C-TCCS-400-TT
• 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