MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-15 for 4C -ES CELL CONTROL 7547189 manufactured by Beckman Coulter, Inc..
[2122742]
Customer reported a potential biohazard event when a normal control vial of 4c -es cell control leaked from the cap when using a coulter ac-t diff 2 analyzer on (b)(6) 2008. The operator was not wearing personal protective equipment. The operator was exposed to the control material, however, there was no exposure to mucous membranes or open lesions. The operator did not seek medical attention. No reports of death or serious injury, and no affect to operator safety as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9243873]
Beckman coulter inc. Product labeling states that ppe must be worn when handling the product. Specifically, labeling states: this specimen/reagent should be handled at biosafety level 2, as recommended for any potentially infectious human serum or blood specimen in the (b)(6) manual "biosafety in microbiological and biomedical laboratories," 1988. Customer canceled a planned field service visit to evaluate the analyzer because the other control vials did not leak. The product was used for approx 15 pierces before it leaked. The open vial claim is that the procedure listed in the instructions for use can be performed a maximum of 20 times within 35 days. Root cause for the failure of the vial stopper was not determined. 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 | 1061932-2011-00571 |
| MDR Report Key | 2175321 |
| Report Source | 05,06 |
| Date Received | 2011-06-15 |
| Date of Report | 2008-10-13 |
| Date of Event | 2008-10-13 |
| Date Mfgr Received | 2008-10-13 |
| Date Added to Maude | 2012-04-23 |
| 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 | 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 -ES CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-06-15 |
| Model Number | NA |
| Catalog Number | 7547189 |
| Lot Number | 079200 |
| ID Number | NA |
| Device Expiration Date | 2009-01-22 |
| 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 | 2011-06-15 |