PHENYTOIN REAGENT 469188

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-05-18 for PHENYTOIN REAGENT 469188 manufactured by Beckman Coulter Inc..

Event Text Entries

[21677492] A customer contacted beckman coulter inc. (bci) to report a leaking phenytoin cartridge. The device was handled with gloves and discarded. No reports of death or injury have been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5


[21745879] The customer was sent a replacement. A clear root cause is unknown at this time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2011-01605
MDR Report Key2092769
Report Source01,06
Date Received2011-05-18
Date of Report2011-04-19
Date of Event2011-04-19
Date Mfgr Received2011-04-19
Device Manufacturer Date2010-07-20
Date Added to Maude2012-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. NORA ZEROUNIAN
Manufacturer Street250 S KRAEMER BOULEVARD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149613634
Manufacturer G1BECKMAN COULTER INC.
Manufacturer Street250 S KRAEMER BOULEVARD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal Code92821
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePHENYTOIN REAGENT
Generic NameTOBRAMYCIN TEST SYSTEM
Product CodeDID
Date Received2011-05-18
Model NumberNA
Catalog Number469188
Lot NumberM004662
ID NumberNA
Device Expiration Date2012-07-31
OperatorHEALTH PROFESSIONAL
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER INC.
Manufacturer Address250 S KRAEMER BOULEVARD BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-05-18

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