MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-17 for COULTER? DXH CLEANER 628022 manufactured by Beckman Coulter, Inc..
[20815007]
A replacement reagent was sent to the customer. Service was not dispatched for this event. A clear root cause for this event has not been determined to date.
Patient Sequence No: 1, Text Type: N, H10
[20840054]
A customer contacted beckman coulter, inc. (bci) in regards to coulter dxh cleaner reagent that was leaking upon receiving. The customer was wearing lab coat, gloves, and eye protection. There was no exposure to mucous membranes or open wounds. No one required medical attention and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2010-00292 |
| MDR Report Key | 1930945 |
| Report Source | 05 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-11-17 |
| Date of Event | 2010-10-15 |
| Date Mfgr Received | 2010-11-17 |
| Date Added to Maude | 2012-01-20 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? DXH CLEANER |
| Generic Name | CLEANING AGENT |
| Product Code | JCB |
| Date Received | 2010-12-17 |
| Model Number | NA |
| Catalog Number | 628022 |
| Lot Number | 2627880 |
| Device Expiration Date | 2011-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| 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 | 2010-12-17 |