MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS; INFLUENZA A+B DIAGNOSTIC TEST STRIP

Model Number 256045

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Chemical Exposure (2570)

Event Date 01/07/2020

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 that bd veritor¿ system for rapid detection of flu a+b, 30 tests reagent sprayed user in the face.Customer stated the plastic vial is not soft and required pressure be applied to the vial in order to place 3 drops on the reagent cartridge.When pressure was applied the top of the vial popped off.The spraying has occurred two times, once on a lab coat and face, and once on the counter.Initially it was reported that the tube contained no patient sample.After additional follow-up it was confirmed the vial contained patient specimen.The customer was not wearing goggles.The customer did not see a physician for the incident, but wiped counter with germicidal wipes, washed hands after removing gloves, and wiped face with tissue to minimize exposure.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS
• Type of Device: INFLUENZA A+B DIAGNOSTIC TEST STRIP
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9644701
• MDR Text Key: 181645974
• Report Number: 3006948883-2020-00041
• Device Sequence Number: 1
• Product Code: PSZ
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Other