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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM

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BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM Back to Search Results
Catalog Number 256089
Device Problem Leak/Splash (1354)
Patient Problem Eye Injury (1845)
Event Date 09/27/2021
Event Type  Injury  
Manufacturer Narrative
Eua # (b)(4). Medical device expiration date: na. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that while testing with bd rapid detection of sars-cov-2 veritor¿ the cap was loose on tube and when mixing reagent the sample went into the operators eye. Operator sought medical attention and blood tests were performed. Eua # (b)(4). The following information was provided by the initial reporter: operator, was using face shield but had flicked it up as shield had fogged up. As he was processing the test, he placed the dropper lid on top of the reagent tube but cap didn't clip into place (was loose). As he flicked the reagent tube to mix, reagent flicked out and went into the operators eye. Medical practitioner was contacted, ordered saline flush and once complete operator went to medical care for full books, as per any body intrusion injury.
 
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Brand NameBD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Type of DeviceCORONAVIRUS ANTIGEN DETECTION SYSTEM
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12693321
MDR Text Key279086615
Report Number1119779-2021-01707
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number256089
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1
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