MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256082

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Eua # (b)(4).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 while testing for sars-cov-2 qc positive reagent splashed on customers forehead, was not wearing ppe's.Customer reported having headache and dizziness, and then went to urgent care clinic.Eua # (b)(4).The following information was provided by the initial reporter: customer is asking for any suggestions on what to do since she got the qc positive reagent splashed on her forehead and having symptoms after that encounter.Told customer to wash contact areas with soap and water.Remove contaminated clothing.Launder contaminated clothing before reuse as per sds(safety data sheet) and ensured her to take the first aid measures listed in the sds.Also, mentioned she should wash her face immediately and contact her doctor.Informed customer to make sure she follows up with her doctor for any problems moving forward and also to follow up when she receives her results in a few days to confirm she is negative with the pcr test in a few days.Additionally, the customer provided the following additional information: customer called back asking for hazardous pay, and will contact her lawyer.Mentioned that splashing on her forehead is user error and we always recommend the use of personal protective equipment when dealing with 256082 material.Also, mentioned that it already states that one should wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated as the safety date sheet explains.Also, our positive control swab is non-infectious, recombinant viral protein antigen with less than 0.1% sodium azide.

Manufacturer Narrative

Investigation summary: this memo is to summarize the investigation results regarding the complaint that alleges broken or damaged components when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch number unknown.Bd quality performs a systematic approach to investigate broken or damaged components complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.An investigation could not be performed as no batch number was provided.The complaint was unable to be confirmed.There are no current trends against broken or damaged components.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported while testing for sars-cov-2 qc positive reagent splashed on customers forehead, was not wearing ppe's.Customer reported having headache and dizziness, and then went to urgent care clinic.Eua # (b)(4) the following information was provided by the initial reporter: customer is asking for any suggestions on what to do since she got the qc positive reagent splashed on her forehead and having symptoms after that encounter.Told customer to wash contact areas with soap and water.Remove contaminated clothing.Launder contaminated clothing before reuse as per sds(safety data sheet) and ensured her to take the first aid measures listed in the sds.Also, mentioned she should wash her face immediately and contact her doctor.Informed customer to make sure she follows up with her doctor for any problems moving forward and also to follow up when she receives her results in a few days to confirm she is negative with the pcr test in a few days.Additionally, the customer provided the following additional information: customer called back asking for hazardous pay, and will contact her lawyer.Mentioned that splashing on her forehead is user error and we always recommend the use of personal protective equipment when dealing with 256082 material.Also, mentioned that it already states that one should wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated as the safety date sheet explains.Also, our positive control swab is non-infectious, recombinant viral protein antigen with less than 0.1% sodium azide.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11701403
• MDR Text Key: 262899957
• Report Number: 1119779-2021-00691
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention