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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
Eua # (b)(4). Medical device expiration date: unknown. Initial reporter state: address information was not able to be obtained, however, (b)(6) was used as a place holder. 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 the customer tested herself using the positive control swab twice. Multiple attempts have been made to obtain additional information, the customer has not responded. Eua # (b)(4). The following information was provided by the initial reporter: customer tested herself with positive control swab and received a positive results then tested her self again with a regular swab and received a negative result, and then tested her self a third time using a positive control swab, which resulted as positive. Customer could not provide lot# or instrument sn. Customer is going to get tested with pcr. Customer does not allege a defect with bd reagents or analyzer. 3 follow up attempts. No response from the customer.
 
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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 Key11634896
MDR Text Key244443293
Report Number1119779-2021-00625
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 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2021
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 Received07/02/2021
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

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