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

Catalog Number 256094

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.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 when using the bd veritor ¿ at-home covid-19 test there was exposure to the reagent as the solution got into the nose of the customer.There was no report of adverse patient impact.Eua# (b)(4).The customer stated: she just made the mistake of putting the nose swab in the liquid and then putting it in her nose with liquid on nose swab.Customer inquiring what she should do.

Manufacturer Narrative

H.6 investigation summary:this summarizes the investigation results regarding the customer alleges ¿dip the swab into the extraction solution and then proceeded to swab her nose" when using the bd veritor at home covid-19 test (material # 256094), batch number 2006644.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 was performed on the batch number provided.Results were acceptable and no relevant issue was found.The complaint was unable to be confirmed.The root cause is the customer not following bd's instruction.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.H3 other text : see h.10.

Event Description

It was reported when using the bd veritor ¿ at-home covid-19 test there was exposure to the reagent as the solution got into the nose of the customer.There was no report of adverse patient impact.Eua# (b)(4).The customer stated: she just made the mistake of putting the nose swab in the liquid and then putting it in her nose with liquid on nose swab.Customer inquiring what she should do.

• 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: 13624926
• MDR Text Key: 288667467
• Report Number: 1119779-2022-00315
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• 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: 07/05/2022
• 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