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

Catalog Number 256094

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter: address unavailable.Bd corporate address used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that a patient has been found exposed to the reagent of the bd veritor ¿ at-home covid-19 test.Eua#(b)(4).The following has been provided by the initial reporter: it was reported that customer experienced a potential safety issue due to exposure to reagent.What medical impact was reported? unknown, potentially toxic.No follow-up provided.What treatment was given? patient was referred to the ed.Specific treatments unknown.How did the customers come in contact with the reagent? route = mouth, no circumstances provided.

Manufacturer Narrative

H6: investigation summary : this summarizes the investigation results regarding a complaint that alleges ¿exposure to¿ the bd veritor at home covid-19 test (material # 256094), batch number unknown, ¿reagent¿.Bd quality performs a systematic approach to investigate safety (chemical exposure) complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation could not be performed because a batch number was not provided.The complaint was unable to be confirmed.The root cause could not be identified.A trend analysis for safety (chemical exposure) was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

Event Description

It has been reported that a patient has been found exposed to the reagent of the bd veritor ¿ at-home covid-19 test.Eua#(b)(4).The following has been provided by the initial reporter: it was reported that customer experienced a potential safety issue due to exposure to reagent.What medical impact was reported? unknown, potentially toxic.No follow-up provided.What treatment was given? patient was referred to the ed.Specific treatments unknown.How did the customers come in contact with the reagent? route = mouth, no circumstances provided.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13389020
• MDR Text Key: 284998010
• Report Number: 1119779-2022-00158
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 256094
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention