MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-24 for BD VERITOR? SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT 256045 manufactured by Becton, Dickinson And Company.
[131319260]
Staff have noticed that when following the procedure and squeezing the vial, the seam of the vial cracks and the liquid seeps out. Staff noticed this when they put the pipette in to aliquot the specimen and they were not getting any fluid in the pipette. They pulled back the sticker and noticed it was wet and then say the crack. We have not noticed the liquid level low prior to testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8193697 |
| MDR Report Key | 8193697 |
| Date Received | 2018-12-24 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-29 |
| Report Date | 2018-12-04 |
| Date Reported to FDA | 2018-12-04 |
| Date Reported to Mfgr | 2018-12-24 |
| Date Added to Maude | 2018-12-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| 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 CLIA-WAVED KIT |
| Generic Name | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C |
| Product Code | GNX |
| Date Received | 2018-12-24 |
| Model Number | 256045 |
| Catalog Number | 256045 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-24 |