MAUDE Adverse Event Report: VERATHON MEDICAL ULC. GLIDERITE RIGID STYLET; RIGID ENDOTRACHEAL STYLET

Model Number 0803-0009

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/23/2014

Event Type  malfunction  

Event Description

A gliderite rigid stylet handle broke off during an intubation.No adverse consequence to the patient was reported.

Manufacturer Narrative

A device evaluation is in process and additional complaint details have been requested from the distributor.

• Brand Name: GLIDERITE RIGID STYLET
• Type of Device: RIGID ENDOTRACHEAL STYLET
• Manufacturer (Section D): VERATHON MEDICAL ULC.; burnabyca-bc ; CA
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, bc V5C 5A9; CA V5C 5A9
• Manufacturer Contact: adam gaines ; 20001 n. creek pkwy; bothell, WA 98011 ; 4256295606
• MDR Report Key: 3965934
• MDR Text Key: 19723722
• Report Number: 9615393-2014-00029
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0803-0009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1