MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-05 for COULTER CLENZ? CLEANING AGENT 8546931 manufactured by Beckman Coulter, Inc..
[1379285]
A customer contacted beckman coulter, inc. (bci) in regards to a shipping box of coulter clenz cleaning agent that was damaged and leaking upon receiving. Less than 15 ml of the clenz agent was cleaned up with paper towels. Personal protective equipment (ppe) was not in use, but there was no exposure of clenz agent to eyes, mouth, or open wounds. No death or injury was associated with this event. No one sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
[8769180]
A replacement clenz agent 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
| Report Number | 1061932-2010-00163 |
| MDR Report Key | 1853408 |
| Report Source | 05 |
| Date Received | 2010-10-05 |
| Date of Report | 2010-10-04 |
| Date of Event | 2010-09-08 |
| Date Mfgr Received | 2010-09-08 |
| Date Added to Maude | 2010-12-01 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI 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 CLENZ? CLEANING AGENT |
| Generic Name | CLEANING AGENT |
| Product Code | JCB |
| Date Received | 2010-10-05 |
| Model Number | NA |
| Catalog Number | 8546931 |
| Lot Number | 102020F |
| 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 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-05 |