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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 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 05/03/2022
Event Type  Injury  
Manufacturer Narrative
Eua# (b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the assistant in nursing used the control swab from the bd rapid detection of sars-cov-2 veritor¿ to test herself, therefore, exposing herself to reagent. Eua# (b)(4). The following information was provided by the initial reporter: the receptionist from care home called to say that an ain (assistant in nursing) didn't follow the instructions of use & used the green swab ( sars cov-2 (+) control swab in green satchel) to perform a sars cov-2 test on herself at 8am this morning & tested positive. The ain repeated the test using a clean swab & tested positive again. There concern was whether the ain became infected by the positive control swab.
 
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Brand NameBD RAPID DETECTION OF SARS-COV-2 VERITOR¿
Type of DeviceCORONAVIRUS ANTIGEN DETECTION SYSTEM
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14578754
MDR Text Key293279236
Report Number3006948883-2022-00125
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
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 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/09/2022
Device Catalogue Number256089
Device Lot Number1270839
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/02/2022 Patient Sequence Number: 1
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