MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-04 for CX/LX DBIL KIT 476856 manufactured by Beckman Coulter Inc..
[1781597]
Customer contacted beckman coulter inc. , (bci) and reported that one bottle of dbil kit was found leaked due to small crack at the bottom of the bottle. No injury was reported on this issue.
Patient Sequence No: 1, Text Type: D, B5
[8871399]
No additional information is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01702 |
| MDR Report Key | 1945188 |
| Report Source | 07 |
| Date Received | 2011-01-04 |
| Date of Report | 2010-11-24 |
| Date of Event | 2010-11-22 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2010-07-09 |
| 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 | 0 |
| 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 | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CX/LX DBIL KIT |
| Generic Name | DIRECT BILIRUBIN REAGENT |
| Product Code | JFM |
| Date Received | 2011-01-04 |
| Model Number | NA |
| Catalog Number | 476856 |
| Lot Number | Z007011 |
| 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 | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-04 |