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 2020-03-18 for BD BBL? GRAM CRYSTAL VIOLET 212525 manufactured by Becton, Dickinson & Co..
[187090512]
Expiration date not provided, lot # not provided. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date not provided.
Patient Sequence No: 1, Text Type: N, H10
[187090513]
The customer reported that while using bd bbl? Gram crystal violet they noticed artifact resembling gram positive cocci and budding yeast. This artifact lead to false positive grams stains being reported. The customer is unaware of any course of treatment change due to these erroneous results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2020-00007 |
| MDR Report Key | 9850593 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-18 |
| 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 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BBL? GRAM CRYSTAL VIOLET |
| Generic Name | DYE AND CHEMICAL SOLUTION STAINS |
| Product Code | JTS |
| Date Received | 2020-03-18 |
| Catalog Number | 212525 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |