MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-10-07 for 4C - ES CELL CONTROL 7547188 manufactured by Beckman Coulter, Inc..
[2230620]
There was a report from the beckman coulter inc (bci) warehouse, the (b)(4) distribution center, of a potential biohazard. It was reported that an inspector identified dried blood on the cap of a vial from a kit of 4c - es cell control. There were no reports of exposure, as the inspector were wearing appropriate personal protective equipment. Product was inspected and identified at a bci warehouse. Product was not distributed. No reports of death or serious injury, and no affect to operator safety as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9371955]
A review for similar events was conducted. This is the only report of this type for 12 months prior to the event. Root cause was not determined. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01598 |
| MDR Report Key | 2320124 |
| Report Source | 01,07 |
| Date Received | 2011-10-07 |
| Date of Report | 2008-10-23 |
| Date of Event | 2008-10-23 |
| Date Mfgr Received | 2008-10-23 |
| Date Added to Maude | 2012-06-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4C - ES CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 7547188 |
| Lot Number | 1686120K |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-07 |