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

Catalog Number 256094

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported that bd veritor ¿ at-home covid-19 test customer put liquid on swab before swabbing their nose.The following information was provided by the initial reporter: the customer stated they put the liquid on the swab before swabbing her nose.They wanted to know would that effect the results because they tested positive.Customer didn't complain about the liquid on the swab.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges ¿customer put the liquid on the swab before swabbing her nose.She wanted to know would that effect the results because she tested positive¿ the bd veritor at home covid-19 test (material # 256094), batch number 1319355, bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation was performed on the batch number provided.Results were acceptable and no relevant issue was found.The tube liquid contains sodium azide.Do not inhale, swallow, or expose to skin and eyes.If the liquid contacts skin, wash immediately with plenty of soap and water.There is no product quality issue were alleged with this complaint.This complaint was unable to be confirmed.The root cause could not be identified.Currently, there are no adverse trends identified for safety (chemical exposure).Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported that bd veritor ¿ at-home covid-19 test customer put liquid on swab before swabbing their nose.The following information was provided by the initial reporter: the customer stated they put the liquid on the swab before swabbing her nose.They wanted to know would that effect the results because they tested positive.Customer didn't complain about the liquid on the swab.

• 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 ; 8448235433
• MDR Report Key: 16444011
• MDR Text Key: 310255563
• Report Number: 1119779-2023-00172
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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 Expiration Date: 05/11/2022
• Device Catalogue Number: 256094
• Device Lot Number: 1319355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1