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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP; ANTIGENS, ALL GROUPS, STREPTOCOCCUS
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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP; ANTIGENS, ALL GROUPS, STREPTOCOCCUS Back to Search Results
Catalog Number 256057
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported while opening pouch with bd veritor(tm) sys for rapid detection of group a strep the tube was broken and leaking.There was no report of user impact.
 
Event Description
It was reported while opening pouch with bd veritor(tm) sys for rapid detection of group a strep the tube was broken and leaking.There was no report of user impact.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3006948883-2021-00155 was sent in error.Physical defect when tubes are broken is not considered to be a reportable malfunction.
 
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Brand Name
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
Type of Device
ANTIGENS, ALL GROUPS, STREPTOCOCCUS
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH 
MDR Report Key11216263
MDR Text Key229642951
Report Number3006948883-2021-00155
Device Sequence Number1
Product Code GTY
Combination Product (y/n)N
PMA/PMN Number
K122718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/06/2021
Device Catalogue Number256057
Device Lot Number9333373
Was Device Available for Evaluation? No
Date Manufacturer Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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