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

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

A return authorization has been set up for the customer to return the device to verathon, but it has not been received yet.This is one of six broken gliderite stylets which the customer collected from (b)(6) 2013 through (b)(6) 2014, and reported all together on (b)(6) 2014.The other five broken stylet complaints are being reported under # 9615393-2014-00015, 9615393-2014-00016, 9615393-2014-00017, 9615393-2014-00018, and 9615393-2014-00019.The customer also stated that to clean the stylets, they were all washed in a washer with getinge detergent at 180-190 degrees for 30 minutes, then peel packed and steam autoclaved at 270 degrees for 5 minutes and let dry for 30 minutes.Getinge detergents may contain potassium hydroxide, which is not an approved cleaning solution in the gliderite rigid stylet instructions for use.

• Brand Name: GLIDERITE RIGID STYLER
• Type of Device: RIGID ENDOTRACHEAL STYLET
• Manufacturer (Section D): VERATHON MEDICAL ULC.; burnaby, ca-bc ; CA
• Manufacturer (Section G): VERATHON MEDICAL ULC.
• Manufacturer Contact: adam gaines ; 20001 n. creek pkwy.; bothell, WA 98011 ; 4256295606
• MDR Report Key: 3804395
• MDR Text Key: 4365647
• Report Number: 9615393-2014-00020
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1