CYTO-STAT/CLONE (C-S) I3-RD1 N/A 6604366

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 2011-06-10 for CYTO-STAT/CLONE (C-S) I3-RD1 N/A 6604366 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2056217] A customer contacted beckman coulter inc. (bci) stating that, upon receiving, liquid was leaking from the cyto-stat/clone (c-s) (b)(4). The liquid adhered to the label. There was no death or injury to the operator as a result of this incident. There was no exposure to open wounds or mucous membranes and the customer did not seek medical attention. The operator was wearing personal protective equipment (ppe): gloves, lab coat and goggles.
Patient Sequence No: 1, Text Type: D, B5


[8981833] Service was not dispatched for this event. No further information was provided by the customer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1061932-2011-00592
MDR Report Key2120750
Report Source01,06
Date Received2011-06-10
Date of Report2011-05-11
Date of Event2011-05-11
Date Mfgr Received2011-05-11
Device Manufacturer Date2011-02-28
Date Added to Maude2012-04-16
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 Street11800 SW 147TH AVENUE
Manufacturer CityMIAMI FL 33196
Manufacturer CountryUS
Manufacturer Postal Code33196
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameCYTO-STAT/CLONE (C-S) I3-RD1
Generic NameCYTO-STAT/CLONE (C-S) I3-RD1 REAGENT
Product CodeMVU
Date Received2011-06-10
Model NumberN/A
Catalog Number6604366
Lot Number7354006F
Device Expiration Date2012-08-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address11800 SW 147TH AVENUE MIAMI FL 33196 US 33196


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-10

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