GLIDERITE RIGID STYLET 0270-0681

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-07 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.

Event Text Entries

[95187019] At the time of this report the gliderite rigid stylet has not been received by verathon, however; the return of the device is anticipated. Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[95187020] The customer reported that the gliderite rigid stylet broke in the endotracheal tube during a patient procedure. The stylet was removed from the endotracheal tube with a surgical tool. No harm to patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615393-2017-00218
MDR Report Key7095653
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-12-07
Date of Report2017-11-09
Date of Event2017-11-07
Date Mfgr Received2017-11-09
Date Added to Maude2017-12-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. COREY KASBOHM
Manufacturer Street20001 N CREEK PKWY
Manufacturer CityBOTHELL WA 980118218
Manufacturer CountryUS
Manufacturer Postal980118218
Manufacturer Phone4256295760
Manufacturer G1VERATHON MEDICAL ULC
Manufacturer Street2227 DOUGLAS ROAD
Manufacturer CityBURNABY, BRITISH COLUMBIA V5C 5A9
Manufacturer CountryCA
Manufacturer Postal CodeV5C 5A9
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGLIDERITE RIGID STYLET
Generic NameSTYLET, TRACHEAL TUBE
Product CodeBSR
Date Received2017-12-07
Model Number0270-0681
Catalog Number0270-0681
Lot NumberUNKNOWN
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVERATHON MEDICAL ULC
Manufacturer Address2227 DOUGLAS ROAD BURNABY, BRITISH COLUMBIA V5C 5A9 CA V5C 5A9


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-07

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