IMMUNOPREP REAGENT SYSTEM, 300 TEST 7546999

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-07-02 for IMMUNOPREP REAGENT SYSTEM, 300 TEST 7546999 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2069676] A customer reported to beckman coulter, inc (bec) that a shipment of immunoprep reagent arrived damaged and the reagent was leaking from all three reagents in the kit. The incident occurred in a beckman coulter warehouse. The operator was wearing lab coat, goggles, and gloves when handling the damaged containers. There was no exposure to open wounds or mucous membranes. The operator did not seek medical attention. The msds was reviewed and there is an exposure control plan in place at the facility. No death or injury occurred as a result of this incident and there was no change to patient treatment.
Patient Sequence No: 1, Text Type: D, B5


[9280199] The root cause for this event is damage to the package during shipping.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1061932-2011-00825
MDR Report Key2148254
Report Source00,01
Date Received2011-07-02
Date of Report2011-06-02
Date of Event2011-06-02
Date Mfgr Received2011-06-02
Device Manufacturer Date2011-04-06
Date Added to Maude2012-05-04
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 NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIMMUNOPREP REAGENT SYSTEM, 300 TEST
Generic NameRED-CELL LYSING PRODUCTS
Product CodeGGK
Date Received2011-07-02
Model NumberNA
Catalog Number7546999
Lot Number1099052K
ID NumberNI
Device Expiration Date2012-06-28
OperatorHEALTH PROFESSIONAL
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 2011-07-02

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