• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM Back to Search Results
Catalog Number 256089
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  Injury  
Event Description
It was reported that the patient was exposed to the positive control reagent of bd rapid detection of sars-cov-2 veritor¿. This is a report of one occurrence. No false results were reported for to the patient or the clinician. Exposure to this the control reagent would not cause the patient to contract covid-19 but could result in a false positive to the patient. The following information was provided by the initial reporter: "it was reported that there was exposure to reagent. Customer problem: customer called in and inquired about the composition of the positive control swab. She wants to know if it can have any harmful effect on patient. The patient had been mistakenly inserted the positive control swab in his nose instead of a normal nasopharyngeal test swab. The test was ran again shortly after the discovery of that mistake. The customer is wondering if the positive cov-2 result she obtained is due to the positive control swab that was inserted previously. I read the sds to her and sent it as well. From what i read to her, i told her i do not believe that it will harm the customer however, she should follow the precaution measures mentioned in the sds. An email was sent to mis to reach out to her about her second question on whether the use of this positive control swab could have led to the positive cov-2 results she obtained. Emerson lovell from mis responded to her and said that "regarding the positive control swabs potential to cause a positive result. The control swab contains recombinant protein which cannot make you sick, but could result in a positive test outcome. If you are not symptomatic, you could retest 24 - 48 hours later or you could take a pcr test" customer is inquiring on the component of positive control swab and if inserted inside of patient' nose can it lead to to a positive cov-2 result".
 
Manufacturer Narrative
Medical device expiration date: none, medical device serial # unknown, medical device batch#: unknown, (b)(4). 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Type of DeviceCORONAVIRUS 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 Key13999485
MDR Text Key288776568
Report Number1119779-2022-00501
Device Sequence Number1
Product Code QKP
UDI-Device Identifier00382902560890
UDI-Public382902560890
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number256089
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2022
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 Treatment Data
Date Received: 04/04/2022 Patient Sequence Number: 1
-
-