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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDERITE RIGID STYLET; RIGID ENDOTRACHEAL STYLET
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VERATHON MEDICAL ULC GLIDERITE RIGID STYLET; RIGID ENDOTRACHEAL STYLET Back to Search Results
Model Number 0270-0681/0803-0009
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2014
Event Type  Injury  
Event Description
The plastic handle of a gliderite rigid stylet broke off during a pt procedure.The customer reported that when the handle breaks, the anesthesia provider sometimes has to utilize magill forceps to remove pieces from the pt airway.The customer also described difficulty removing the stylet out of the endotracheal tube without the handle.In some cases it has to be removed with an instrument.There was no pt harm.
 
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Brand Name
GLIDERITE RIGID STYLET
Type of Device
RIGID ENDOTRACHEAL STYLET
Manufacturer (Section D)
VERATHON MEDICAL ULC
burnaby, ca-bc
CA 
Manufacturer (Section G)
VERATHON INCORPORATED
21222 30th drive se, ste. 120
bothell WA 98021 701
Manufacturer Contact
21222 30th drive se, ste. 120
bothell, WA 98021-7012
MDR Report Key3804373
MDR Text Key21725378
Report Number3022472-2014-00015
Device Sequence Number1
Product Code BSR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/24/2014,03/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0270-0681/0803-0009
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2014
Distributor Facility Aware Date03/25/2014
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/25/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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