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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ AT-HOME COVID-19 TEST NOT CLASSIFIED

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BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ AT-HOME COVID-19 TEST NOT CLASSIFIED Back to Search Results
Catalog Number 256094
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
It was reported that one of the test sticks in the bd veritor¿ at-home covid-19 test was missing. There was no report of patient impact and no confirmatory testing took place. The following information was provided by the initial reporter: problem description: received a case of kits for r&d studies. One of the test-sticks was missing a bar code or other printing. Date of event or issue: (b)(6) 2021. Lot number (on outside of box by the qr code): 1277179. Was there any report of adverse medical impact? if so what? no.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Product is eua. (b)(4).
 
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Brand NameBD VERITOR¿ AT-HOME COVID-19 TEST
Type of DeviceNOT CLASSIFIED
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 Key12798678
MDR Text Key284888627
Report Number1119779-2021-01803
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/22/2022
Device Catalogue Number256094
Device Lot Number1277179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2021
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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