COULTER 4C CELL CONTROL, TRI-PACK 7547187

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 2011-10-07 for COULTER 4C CELL CONTROL, TRI-PACK 7547187 manufactured by Beckman Coulter, Inc..

Event Text Entries

[16121754] The customer had contacted beckman coulter, inc. (bec) to report that a vial of their coulter 4c cell control, tri-pack leaked due to a crack in the cap while mixing the vial before assaying. The customer was wearing personal protective equipment at the time of the event. Approximately 1 ml of coulter 4c cell control leaked onto the customer's pant leg, shoes, and the floor. There was no exposure to mucous membranes or open lesions. There was no report of death or serious injury associated with this event. Medical attention was not sought. The laboratory has a risk management plan in place. The material safety data sheet (msds) was available, but was not reviewed by the customer at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


[16337327] Product labeling states: "beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer. " the control vial was disposed of the customer into a biohazard sharps container. The root cause was not determined. Product labeling contains sufficient warnings/precautions addressing potential biohazard events. This reportable event was identified during a retrospective review conducted between january 01, 2008 and october 23, 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1061932-2011-01649
MDR Report Key2320056
Report Source05,06
Date Received2011-10-07
Date of Report2009-07-30
Date of Event2009-07-01
Date Mfgr Received2009-07-30
Date Added to Maude2012-06-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
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 Street11800 SW 147TH AVE.
Manufacturer CityMIAMI FL 33196
Manufacturer CountryUS
Manufacturer Postal Code33196
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOULTER 4C CELL CONTROL, TRI-PACK
Product CodeJPK
Date Received2011-10-07
Model NumberNA
Catalog Number7547187
Lot Number1685147K
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address11800 SW 147TH AVE. MIAMI FL 33196 US 33196


Patients

Patient NumberTreatmentOutcomeDate
10 2011-10-07

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