MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for BD SERO-FUGE? 2002 CENTRIFUGE, 2 SPEED, 115V 420352 manufactured by Becton, Dickinson & Co..
[105277357]
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
[105277358]
It was reported that a bd sero-fuge? 2002 centrifuge, 2 speed, 115v sparked, overheated and now spins with the lid open. No injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2018-00007 |
| MDR Report Key | 7414851 |
| Date Received | 2018-04-10 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2015-05-23 |
| Date Added to Maude | 2018-04-10 |
| 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 |
| 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 | 0 |
| Brand Name | BD SERO-FUGE? 2002 CENTRIFUGE, 2 SPEED, 115V |
| Generic Name | CENTRIFUGE |
| Product Code | LXG |
| Date Received | 2018-04-10 |
| Catalog Number | 420352 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-04-10 |