MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-20 for CX TOTAL/DIRECT BILIRUBIN CALIBRATOR N/A 465915 manufactured by Beckman Coulter Inc..
[1681891]
A customer contacted beckman coulter inc. (bci) stating that a lab technician cut her finger while handling an opened direct bilirubin (dbil) calibrator ampule vial. The lab technician was not wearing gloves as she opened the ampule vial that was wrapped in parafilm. The lab technician will do a baseline monitor for 6 weeks and 3 months testing for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[8878498]
The bci hotline advised the customer that bci makes every attempt to make sure no infectious material is in the contents. The bci hotline forwarded the dbil calibrator msds to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01689 |
| MDR Report Key | 1932619 |
| Report Source | 05 |
| Date Received | 2010-12-20 |
| Date of Report | 2010-11-19 |
| Date of Event | 2010-11-19 |
| Date Mfgr Received | 2010-11-19 |
| Date Added to Maude | 2012-01-23 |
| 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 | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CX TOTAL/DIRECT BILIRUBIN CALIBRATOR |
| Generic Name | DIRECT BILIRUBIN CALIBRATOR |
| Product Code | JIS |
| Date Received | 2010-12-20 |
| Model Number | N/A |
| Catalog Number | 465915 |
| Lot Number | NOT LOT SPECIFIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-20 |