MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for BD SERO-FUGE? 2001 CENTRIFUGE, 1 SPEED, 115V 420351 manufactured by Becton, Dickinson & Co..
[123371823]
(b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Based on the provided serial number, this device was the 18th device with this catalog number manufactured in dec. 2005.
Patient Sequence No: 1, Text Type: N, H10
[123371824]
It was reported that a bd sero-fuge? 2001 centrifuge, 1 speed, 115v was spinning with the lid open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2018-00013 |
| MDR Report Key | 7954282 |
| Date Received | 2018-10-10 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-10-10 |
| 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 |
| 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 | 0 |
| Brand Name | BD SERO-FUGE? 2001 CENTRIFUGE, 1 SPEED, 115V |
| Generic Name | EQUIPMENT, LABORATORY, GENERAL PURPOSE |
| Product Code | LXG |
| Date Received | 2018-10-10 |
| Catalog Number | 420351 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-10 |