MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-28 for BD VERITOR SYSTEM - FLU A & B 256045 manufactured by Bd Diagnostics Systems.
[5321375]
Customer reported that while adjusting the dropper tip of a veritor flu a & b specimen tube, the technician accidentally got an aerosol of reagent and specimen in her eye. The technician was not wearing protective eye wear or glasses. Technician was examined by an eye doctor and no injury was found. Patient sample was tested for flu and determined to be negative. The bd veritor system for rapid detection of flu a+b is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza a and b viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The bd veritor system for rapid detection of flu a+b is a differentiated test, such that influenza b viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza a and b viral infections.
Patient Sequence No: 1, Text Type: D, B5
[12798943]
Bd quality has investigated the customer's complaint of an aerosol from reagent d from the veritor system flu a+b test getting into a tech's eye. This complaint was not confirmed. The manufacturing batch history records were examined for bd veritor system for rapid detection of flu a+b kit lot number 4018215 and showed no performance-related issues that can be correlated to this complaint. Additional investigation and testing of the reagent tubes and tips included in retention kit lot number 4018215 showed that the caps can easily open, the tubes and tips fastened securely, and no leaks or cracks were present during reagent dispensing. As defects were not found in either the design or in the performance of the kit's tubes and tips, this issue could not be correlated with the quality of the product. Bd has had no other complaints of this defect and will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2015-00002 |
| MDR Report Key | 4470611 |
| Report Source | 06 |
| Date Received | 2015-01-28 |
| Date of Report | 2014-12-30 |
| Date of Event | 2014-12-30 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-02-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 3164367 |
| Manufacturer G1 | BD RAPID DIAGNOSTICS CO. LTD. |
| Manufacturer Street | 9 RUI PU RD |
| Manufacturer City | SUZHOU JIANGSU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VERITOR SYSTEM - FLU A & B |
| Product Code | GNX |
| Date Received | 2015-01-28 |
| Catalog Number | 256045 |
| Lot Number | 4018215 |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTICS SYSTEMS |
| Manufacturer Address | SPARKS MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-28 |