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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD IMMUNOASSAY PLUS CONTROL, 5 ML
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BIO-RAD IMMUNOASSAY PLUS CONTROL, 5 ML Back to Search Results
Device Problem Material Integrity Problem (2978)
Patient Problems Exposure to Body Fluids (1745); Injury (2348)
Event Date 01/07/2016
Event Type  Injury  
Event Description
I am a medical technologist.I work at (b)(6).I want to report a product quality problems of bio-rad company.On (b)(6) 2016 at 10:40 am, when i opened the cp of a new "immunoassay plus control" which is a product by bio-rad of american company, my right thumb was injured by the glass fragment around the neck of vial.The glass fragment was so big that it caused uncontrolled bleeding.The wound was very painful.I used the "immunoassay plus control" for thyroid gland disease.At the same time i am in charge of (b)(6) test.I deal with pt specimens of an infection disease.On (b)(6) 2016 before 10:40 am, several pts carried virus on (b)(6) were confirmed.It is so dangerous that when i deal with pts' who carried (b)(6) virus i was injured.It is possible that i am infected by infection virus.Dates of use: 3 years.Reason for use: is a part of work.Product is not compounded.Product is not over-the-counter.Event abated after use: stopped or dose reduced? no.Event reappeared after reintroduction? no.
 
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Brand Name
IMMUNOASSAY PLUS CONTROL, 5 ML
Type of Device
IMMUNOASSAY PLUS CONTROL, 5 ML
Manufacturer (Section D)
BIO-RAD
MDR Report Key5551775
MDR Text Key42162976
Report NumberMW5061487
Device Sequence Number1
Product Code JJY
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/01/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
Patient Weight50
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