MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for 4C PLUS COULTER CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[2125470]
Customer reported a potential biohazard when using the 4c plus coulter cell control. Customer reported that upon receipt, the abnormal high vial had leaked due to a loose cap. Operator was wearing personal protective equipment and there was no exposure to mucous membranes or open lesions. No reports of death or serious injury, and no effect to pt treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9206604]
The other two control levels within the kit did not exhibit this issue. The product was discarded by the customer and therefore not available for eval. There have been no other reported events for leaking vials upon receipt for 4c plus coulter cell control within the past 12 months. Root cause is unk. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00772 |
| MDR Report Key | 2171360 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2008-03-17 |
| Date of Event | 2008-03-17 |
| Date Mfgr Received | 2008-03-17 |
| Device Manufacturer Date | 2008-03-05 |
| Date Added to Maude | 2012-05-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4C PLUS COULTER CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 1000112K |
| ID Number | NA |
| Device Expiration Date | 2008-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-01 |