CIAGLIA BLUE RHINO INTRODUCER TRAY C-PTISY-100-HC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-06-18 for CIAGLIA BLUE RHINO INTRODUCER TRAY C-PTISY-100-HC manufactured by Cook, Inc..

Event Text Entries

[18327390] When advancing the dilator over the white guiding catheter, it went past the safety ridge. The physician had to convert to an open tracheostomy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1820334-2004-00371
• MDR Report Key: 530364
• Report Source: 05
• Date Received: 2004-06-18
• Date of Report: 2004-05-24
• Date of Event: 2004-05-24
• Date Facility Aware: 2004-05-24
• Report Date: 2004-05-24
• Date Mfgr Received: 2004-05-24
• Date Added to Maude: 2004-06-21
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: RITA HARDEN
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal: 47404
• Manufacturer Phone: 8123392235
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CIAGLIA BLUE RHINO INTRODUCER TRAY
• Generic Name: SPECIAL SET
• Product Code: KCG
• Date Received: 2004-06-18
• Model Number: NA
• Catalog Number: C-PTISY-100-HC
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 519594
• Manufacturer: COOK, INC.
• Manufacturer Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US
• Baseline Brand Name: CIAGLIA BLUE RHINO INTRODUCER TRAY
• Baseline Generic Name: SPECIAL SET
• Baseline Model No: NA
• Baseline Catalog No: C-PTISY-100-HC
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-06-18