MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-28 for 4C PLUS COULTER CELL CONTROL 7547025 manufactured by Beckman Coulter, Inc..
[2296425]
Upon opening 4c plus cell control product that had just been received by the laboratory, the customer observed that one vial of the normal control material had leaked. When examined by the customer, the vial was seen to be broken after its cap was removed. There was no visible damage to the shipping container or to the box containing the broken vial of control product. It is unknown what personal protective equipment (ppe) the operator was wearing; however, the customer indicated there was no exposure of potentially biohazardous material to mucous membranes or open skin lesions. The operator did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[9370501]
This reportable event was identified during a retrospective review conducted for the period between january 1, 2008 and october 23, 2010 of complaints for additional reportable events. Product was replaced at the time of the event. Field service was not dispatched. Based upon available information, the root cause of the broken vial is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01994 |
| MDR Report Key | 2320289 |
| Report Source | 05,06 |
| Date Received | 2011-10-28 |
| Date of Report | 2009-06-15 |
| Date of Event | 2009-06-15 |
| Date Mfgr Received | 2009-06-15 |
| Date Added to Maude | 2012-07-10 |
| 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 PLUS COULTER CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-10-28 |
| Model Number | NA |
| Catalog Number | 7547025 |
| Lot Number | 1109158K |
| ID Number | NA |
| 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 | 11800 SW 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-28 |