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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 256082
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while testing for sars cov-2 sample leakage was observed in 19 cartridges. There was no report of impact. Eua#: (b)(4). The following information was provided by the initial reporter: "19 cartridges found minor leak after the 15mins incubation time, before inserted the cartridge into the analyzer. C line are seen on these 19 cartridges, result of these 19 cartridges is negative. After inserted these 19 cartridges into the analyzer, the leakage is more obvious after pulling out from the analyzer base on the moist level. ".
 
Manufacturer Narrative
This complaint should be considered cancelled. This particular event would require the user to acquire replacement material in order to use as intended. This event results in user dissatisfaction. These physical defects do not negatively affect the results, and would render the product unusable. This is not a reportable event.
 
Event Description
It was reported while testing for sars cov-2 sample leakage was observed in 19 cartridges. There was no report of impact. Eua#: (b)(4). The following information was provided by the initial reporter: "19 cartridges found minor leak after the 15mins incubation time, before inserted the cartridge into the analyzer. C line are seen on these 19 cartridges, result of these 19 cartridges is negative. After inserted these 19 cartridges into the analyzer, the leakage is more obvious after pulling out from the analyzer base on the moist level. ".
 
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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)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11975945
MDR Text Key267142469
Report Number3006948883-2021-00677
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/18/2021
Device Catalogue Number256082
Device Lot Number1012038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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