MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-02-24 for CITRANOX 81912 manufactured by Beckman Coulter, Inc..
[14967358]
A customer contacted beckman coulter inc (bci) in regards to receiving a bottle of citranox that was leaking. There was no report of injury.
Patient Sequence No: 1, Text Type: D, B5
[15453071]
From the picture supplied by the customer, the cardboard shipping carton shows evidence of leaking on both inside and outside. The contents of the bottle leaked due to no cap on the bottle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2011-00495 |
| MDR Report Key | 2001188 |
| Report Source | 01,06 |
| Date Received | 2011-02-24 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-25 |
| Date Mfgr Received | 2011-01-25 |
| Date Added to Maude | 2011-10-05 |
| 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 | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CITRANOX |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 2011-02-24 |
| Model Number | NA |
| Catalog Number | 81912 |
| Lot Number | O11463 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-24 |