MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-01-29 for BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS 256045 manufactured by Bd Rapis Diagnostics (suzhou) Co. Ltd..
[181645974]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[181645975]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2020-00041 |
| MDR Report Key | 9644701 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Manufacturer Street | 9 RUI PU ROAD EXPORT ZONE B |
| Manufacturer City | SUZHOU |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B, 30 TESTS |
| Generic Name | INFLUENZA A+B DIAGNOSTIC TEST STRIP |
| Product Code | PSZ |
| Date Received | 2020-01-29 |
| Model Number | 256045 |
| Catalog Number | 256045 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Manufacturer Address | 9 RUI PU ROAD EXPORT ZONE B SUZHOU US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-29 |