MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for BD ADAMS? COMPACT II CENTRIFUGE 420225 manufactured by Becton, Dickinson & Co..
[120527696]
For oem manufacturing sites: in this mdr, bd ds headquarters in sparks, md has been listed =as oem - the (b)(4) is an oem manufacturing site. 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 214th device with this catalog number manufactured in jan. 1993.
Patient Sequence No: 1, Text Type: N, H10
[120527701]
It was reported that a bd adams? Compact ii centrifuge was spinning with the lid open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2018-00012 |
| MDR Report Key | 7879111 |
| Date Received | 2018-09-14 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-28 |
| Date Added to Maude | 2018-09-14 |
| 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 ADAMS? COMPACT II CENTRIFUGE |
| Generic Name | GENERAL PURPOSE LABORATORY EQUIPMENT |
| Product Code | LXG |
| Date Received | 2018-09-14 |
| Catalog Number | 420225 |
| 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 | 2018-09-14 |