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

Catalog Number 256094

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that while using bd veritor ¿ at-home covid-19 test, there is an incorrect expiration date on product beyond the specified shelf life.No patient impact reported.The following information was provided by the initial reporter: "the kit is expired but the test card expiration date is 12/23.".

Manufacturer Narrative

D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.E.1.Initial reporter state: address is unknown, therefore, md has been used in its place.G.5.Pma / 510(k)#: eua# (b)(4).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-00944 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd veritor ¿ at-home covid-19 test, there is an incorrect expiration date on product beyond the specified shelf life.No patient impact reported.The following information was provided by the initial reporter: "the kit is expired but the test card expiration date is 12/23.".

• Brand Name: BD VERITOR ¿ AT-HOME COVID-19 TEST
• Type of Device: NOT 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17627050
• MDR Text Key: 322768588
• Report Number: 1119779-2023-00944
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/26/2023
• 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 Sequence Number: 1