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 Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.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 exposure to bd rapid detection of sars-cov-2 veritor¿ has occurred.Eua# (b)(4).The following has been provided by the initial reporter: called the patient and he mentions that he is sick.Some f the symptoms he provided is : pain in nose, eye, back and chest.Patient states that he seeks medical attention but didn't mention what happen with him to the doctor.Caller stated he received a veritor covid test at hospital.Inquirer stated the rn swabbed one nostril and put the swab in the transport medium.Using the same swab the rn swabbed the pt.Other nostril.Inquirer wanted to know if the substance in the transport medium causes any adverse reactions.

Manufacturer Narrative

Medical device expiration date: unknown.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 exposure to bd rapid detection of sars-cov-2 veritor¿ has occurred.Eua#201889.The following has been provided by the initial reporter: called the patient and he mentions that he is sick.Some f the symptoms he provided is : pain in nose, eye, back and chest.Patient states that he seeks medical attention but didn't mention what happen with him to the doctor.Caller stated he received a veritor covid test at hospital.Inquirer stated the rn swabbed one nostril and put the swab in the transport medium.Using the same swab the rn swabbed the pt.Other nostril.Inquirer wanted to know if the substance in the transport medium causes any adverse reactions.

Event Description

It has been reported that exposure to bd rapid detection of sars-cov-2 veritor¿ has occurred.Eua#(b)(4).The following has been provided by the initial reporter: called the patient and he mentions that he is sick.Some f the symptoms he provided is : pain in nose , eye, back and chest.Patient states that he seeks medical attention but didn't mention what happen with him to the doctor.Caller stated he received a veritor covid test at hospital.Inquirer stated the rn swabbed one nostril and put the swab in the transport medium.Using the same swab the rn swabbed the pt.Other nostril.Inquirer wanted to know if the substance in the transport medium causes any adverse reactions.

Manufacturer Narrative

Change in reportability.This complaint is no longer reportable.The initial mdr was completed against the incorrect material #.A new mdr will be submitted with the appropriate product.This mfr.Report # 1119779-2022-00174 is void.

• 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
• 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: 13419412
• MDR Text Key: 285404322
• Report Number: 1119779-2022-00174
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 256082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 02/15/2022
• 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
• Patient Age: 48 YR
• Patient Sex: Male