GLIDERITE? SINGLE-USE STYLET 0270-0916 0803-0118

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-19 for GLIDERITE? SINGLE-USE STYLET 0270-0916 0803-0118 manufactured by Verathon Medical Ulc.

Event Text Entries

[139306400] 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


[139306401] Verathon received a user facility report stating that during a patient procedure, using a gliderite single use stylet, the stylet broke inside the endotracheal (et) tube. During a follow up call the customer stated that the respiratory therapist (rt) was using the stylet to intubate a twelve day old infant. The initial attempt to intubate the patient with a single lumen et tube was unsuccessful. The et tube , with the stylet still inserted, was removed from the patient's mouth. The rt used the same single use stylet and with a dual lumen et tube to successfully intubate the patient. Reportedly the patient arrived at the hospital with the et tube and stylet still in place. The patient was ventilating and was well oxygenated upon arrival at the hospital, however the patient passed away due to unrelated complications. When the et tube was removed it was noted that stylet, which had remained in the et tube, had broken but remained inside the et tube. The customer indicated that the patient outcome was not a result of the broken stylet.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615393-2019-00056
MDR Report Key8434867
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-03-19
Date of Report2019-02-18
Date of Event2019-02-01
Date Mfgr Received2019-02-18
Date Added to Maude2019-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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? SINGLE-USE STYLET
Generic NameSTYLET, TRACHEAL TUBE
Product CodeBSR
Date Received2019-03-19
Model Number0270-0916
Catalog Number0803-0118
Lot NumberGS43228
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2019-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.