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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 256082
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative
Eua # (b)(4). Medical device expiration date: unknown. 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 while testing for sars-cov-2 qc positive reagent splashed on customers forehead, was not wearing ppe's. Customer reported having headache and dizziness, and then went to urgent care clinic. Eua # (b)(4). The following information was provided by the initial reporter: customer is asking for any suggestions on what to do since she got the qc positive reagent splashed on her forehead and having symptoms after that encounter. Told customer to wash contact areas with soap and water. Remove contaminated clothing. Launder contaminated clothing before reuse as per sds(safety data sheet) and ensured her to take the first aid measures listed in the sds. Also, mentioned she should wash her face immediately and contact her doctor. Informed customer to make sure she follows up with her doctor for any problems moving forward and also to follow up when she receives her results in a few days to confirm she is negative with the pcr test in a few days. Additionally, the customer provided the following additional information: customer called back asking for hazardous pay, and will contact her lawyer. Mentioned that splashing on her forehead is user error and we always recommend the use of personal protective equipment when dealing with 256082 material. Also, mentioned that it already states that one should wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated as the safety date sheet explains. Also, our positive control swab is non-infectious, recombinant viral protein antigen with less than 0. 1% sodium azide.
 
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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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11701403
MDR Text Key262899957
Report Number1119779-2021-00691
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number256082
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
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: 04/21/2021 Patient Sequence Number: 1
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