MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-24 for COULTER? CLENZ AGENT (10 LITERS) 8546931 manufactured by Beckman Coulter Inc..
[14965227]
A customer contacted beckman coulter inc. (bec) stating that a clenz container arrived with a loose cap and 5 to 10cc of the reagent leaked. The container did not appear to be damaged from shipment. The customer was wearing personal protective equipment (ppe) consisting of gloves and lab coat at the time of the incident. No injury or exposure was reported and medical attention was not sought.
Patient Sequence No: 1, Text Type: D, B5
[15174100]
The customer discarded the leaking container. Replacement product was sent to the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01508 |
| MDR Report Key | 2262819 |
| Report Source | 06 |
| Date Received | 2011-09-24 |
| Date of Report | 2011-08-25 |
| Date of Event | 2011-08-25 |
| Date Mfgr Received | 2011-08-25 |
| Device Manufacturer Date | 2011-06-16 |
| Date Added to Maude | 2012-06-27 |
| 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 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 AVENUE, |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER? CLENZ AGENT (10 LITERS) |
| Generic Name | GENERAL PURPOSE REAGENT |
| Product Code | JCB |
| Date Received | 2011-09-24 |
| Model Number | NA |
| Catalog Number | 8546931 |
| Lot Number | 102077F |
| ID Number | NI |
| Device Expiration Date | 2012-06-15 |
| 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 | 2011-09-24 |