MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR SYSTEM RSV; ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Catalog Number 256046

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

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 that prior to use with bd veritor ¿ system rsv the reagent had leaked inside the kit.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3006948883-2021-00175 was sent in error.Physical defect of reagent leaking in kit is not considered to be a reportable malfunction.

Event Description

It was reported that prior to use with bd veritor ¿ system rsv the reagent had leaked inside the kit.

• Brand Name: BD VERITOR SYSTEM RSV
• Type of Device: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 11263392
• MDR Text Key: 232514721
• Report Number: 3006948883-2021-00175
• Device Sequence Number: 1
• Product Code: GQG
• Combination Product (y/n): N
• PMA/PMN Number: K132456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/18/2021
• Device Catalogue Number: 256046
• Device Lot Number: 9234576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1