MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-24 for 4C-ES CELL CONTROL 7547188 manufactured by Beckman Coulter, Inc..
[2126386]
Customer reported a potential biohazard when the abnormal low control vial of 4c -es cell control was leaking from a crack at the top of the vial. Operator was wearing personal protective equipment at the time of the event. There was no exposure to mucous membranes or open lesions. 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
[9140989]
Product 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 centers for disease control/(b)(4) manual "biosafety in microbiological and biomedical laboratories, " 1988. " the field service engineer reported using the abnormal low control vial at initial opening of the vial two (2) days prior to event date and vials were fine. The product was discarded by the customer and therefore not available for evaluation. No other similar reported events within the past 12 months for this lot number. Root cause is unk. This reportable event was identified during a retrospective review conducted between january 1, 2008 and october 23, 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00687 |
| MDR Report Key | 2172318 |
| Report Source | 05,06 |
| Date Received | 2011-06-24 |
| Date of Report | 2008-01-10 |
| Date of Event | 2008-01-09 |
| Date Mfgr Received | 2008-01-10 |
| Date Added to Maude | 2012-05-02 |
| 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 | 2011-06-24 |
| Model Number | NA |
| Catalog Number | 7547188 |
| Lot Number | 1686080K |
| ID Number | NA |
| Device Expiration Date | 2008-04-10 |
| 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 | 2011-06-24 |