MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-01-15 for BD BACTEC? FX, INSTRUMENT TOP, PACKAGED 441385 manufactured by Becton, Dickinson & Co..
[133182957]
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[133182958]
It was reported that a bd bactec? Fx, instrument top, packaged, was placed on the edge of a table and supported with an external bracket of unknown origin. While the user was opening the drawer of the instrument the external bracket and a portion of the table broke loose causing the instrument to fall to the floor. When the instrument fell it struck the user causing unspecified injury. The user received a medical evaluation following the incident for their injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2018-00018 |
| MDR Report Key | 8249858 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-01-15 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2014-03-27 |
| Date Added to Maude | 2019-01-15 |
| 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 | 8015652845 |
| 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 BACTEC? FX, INSTRUMENT TOP, PACKAGED |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2019-01-15 |
| Catalog Number | 441385 |
| 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. Required No Informationntervention | 2019-01-15 |