COULTER FLOW COUNT 7547053

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-11-15 for COULTER FLOW COUNT 7547053 manufactured by Beckman Coulter, Inc..

Event Text Entries

[2357916] The customer reported that when he was removing the foil from the top of a vial of flow-count with scissors, he cut the index finger of his left hand. At the time of the injury he was wearing a lab coat and goggles but he was not wearing gloves as instructed in both the msds (material safety data sheet) and product's instructions for use. The operator sought first aid for the cut on his finger. The wound was cleaned with alcohol with a band-aid applied. He returned to work the same day. Coulter flow count is used in conjunction with the coulter fc 500 flow cytometer.
Patient Sequence No: 1, Text Type: D, B5


[9463284] This reportable event was identified during a retrospective review conducted for the period between (b)(4), 2008 and (b)(4), 2010 of complaints for additional reportable events. Per the flow count package insert sheet (pn (b)(4)) statement of warnings: this reagent contains 1 percent formaldehyde. Avoid contact with skin and eyes as formaldehyde may cause irreversible effects to these tissues. Do not breathe vapors. Wear appropriate safety equipment such as gloves and eye protection. All the aluminum from the heat seal must be removed from the top of the bottle. Residual aluminum reacts with the formaldehyde and may cause a change in the appearance of the flow-count fluorospheres. Field service was not dispatched for this event. Root cause may be attributed to improper laboratory practices.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1061932-2011-02131
MDR Report Key2339997
Report Source01,05,06
Date Received2011-11-15
Date of Report2010-08-27
Date of Event2010-08-27
Date Mfgr Received2010-08-27
Date Added to Maude2012-07-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 FLOW COUNT
Product CodeJPK
Date Received2011-11-15
Model NumberNA
Catalog Number7547053
Lot Number7548077F
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER, INC.
Manufacturer Address11800 SW 147TH AVE. MIAMI FL 33196 US 33196


Patients

Patient NumberTreatmentOutcomeDate
10 2011-11-15

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