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 -ES CELL CONTROL 7547187 manufactured by Beckman Coulter, Inc..
[2137205]
Customer reported potential biohazard when the vials of all levels of controls in the 4c -es cell control kit were leaking due to broken caps. The operator was wearing personal protective equipment and observed hazardous material clean-up procedures. 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. This event represents event 1 of 2 events reported by this customer. The other event is a malfunction of the analyzer used with these controls.
Patient Sequence No: 1, Text Type: D, B5
[9211910]
Customer indicated the caps are breaking up when vials were changed and also leaking after the first use. The old vial was discarded by the customer. Requested return of the new vial for eval. Return product was not received for eval. Complaint history was reviewed. There have been no complaints for caps breaking in the past 12 months. There is no known root cause for the caps of the control vials breaking. This reportable event was identified during a retrospective review conducted between (b)(4) 2008 and (b)(4) 2010 of complaints for additional reportable events. This mdr represents event 1 of 2 reported by this customer. This mdr is related to the following mdrs that have been reported: mdr 1061932-2011-00787.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00777 |
| MDR Report Key | 2171214 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2008-04-02 |
| Date of Event | 2008-04-02 |
| Date Mfgr Received | 2008-04-02 |
| Device Manufacturer Date | 2008-01-17 |
| 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 |
| 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 | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 7547187 |
| Lot Number | 1685080K |
| ID Number | NA |
| Device Expiration Date | 2008-05-15 |
| 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 |