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 Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2022

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 while testing with the bd veritor ¿ at-home covid-19 test, an allergic reaction occurred due to exposure.The following has been provided by the initial reporter: it was reported by the customer that they experienced an itchy throat and coughing after spilling a test component on their hand.¿not sure if i accidentally inhaled the test tube liquid because it spilled a little on my hand when i opened it.I¿m coughing and my throat is a little itchy.¿.

Manufacturer Narrative

H6 investigation summary : this summarizes the investigation results regarding a complaint that alleges ¿customer experienced an itchy throat and coughing after spilling a test component (reagent) on hand¿ from the bd veritor at home covid-19 test (material # 256094), batch number unknown.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.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 has been reported that while testing with the bd veritor ¿ at-home covid-19 test, an allergic reaction occurred due to exposure.The following has been provided by the initial reporter: it was reported by the customer that they experienced an itchy throat and coughing after spilling a test component on their hand.¿not sure if i accidentally inhaled the test tube liquid because it spilled a little on my hand when i opened it.I¿m coughing and my throat is a little itchy.¿.

• 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: 13296441
• MDR Text Key: 284308394
• Report Number: 1119779-2022-00061
• 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: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 07/20/2022
• 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): Other