SYNCHRON? SYSTEM PHOSPHORUS REAGENT A09426

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-26 for SYNCHRON? SYSTEM PHOSPHORUS REAGENT A09426 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2270072] A customer reported to beckman coulter, inc. (bec) that they received a shipment of synchron system phosphorus reagent, and found the reagent cartridge leaked and saturated the box. Bec customer technical support (cts) recommended the use of ppe before handling the leaked cartridge. Msds was reviewed, and the facility has an exposure control plan. There was no exposure to uncovered wounds or mucous membranes. No injury was reported. The operator did not seek medical attention and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5


[9259031] Replacement reagent was sent to the customer. The root cause for the leak is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2050012-2011-04723
MDR Report Key2224605
Report Source05,06
Date Received2011-08-26
Date of Report2011-07-29
Date of Event2011-07-29
Date Mfgr Received2011-07-29
Device Manufacturer Date2011-04-25
Date Added to Maude2012-05-17
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 BLVD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal92821
Manufacturer Phone7149613634
Manufacturer G1BECKMAN COULTER, INC
Manufacturer Street250 S KRAEMER BLVD
Manufacturer CityBREA CA 92821
Manufacturer CountryUS
Manufacturer Postal Code92821
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSYNCHRON? SYSTEM PHOSPHORUS REAGENT
Generic NamePHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUS
Product CodeCEO
Date Received2011-08-26
Model NumberNA
Catalog NumberA09426
Lot NumberM104139
Device Expiration Date2013-04-30
OperatorHEALTH PROFESSIONAL
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address250 S KRAEMER BLVD BREA CA 92821 US 92821


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-26

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