MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-06-10 for CYTO-STAT/CLONE (C-S) I3-RD1 N/A 6604366 manufactured by Beckman Coulter, Inc..
[2056217]
A customer contacted beckman coulter inc. (bci) stating that, upon receiving, liquid was leaking from the cyto-stat/clone (c-s) (b)(4). The liquid adhered to the label. There was no death or injury to the operator as a result of this incident. There was no exposure to open wounds or mucous membranes and the customer did not seek medical attention. The operator was wearing personal protective equipment (ppe): gloves, lab coat and goggles.
Patient Sequence No: 1, Text Type: D, B5
[8981833]
Service was not dispatched for this event. No further information was provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00592 |
| MDR Report Key | 2120750 |
| Report Source | 01,06 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-11 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2011-05-11 |
| Device Manufacturer Date | 2011-02-28 |
| Date Added to Maude | 2012-04-16 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTO-STAT/CLONE (C-S) I3-RD1 |
| Generic Name | CYTO-STAT/CLONE (C-S) I3-RD1 REAGENT |
| Product Code | MVU |
| Date Received | 2011-06-10 |
| Model Number | N/A |
| Catalog Number | 6604366 |
| Lot Number | 7354006F |
| Device Expiration Date | 2012-08-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-10 |