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 7547114 manufactured by Beckman Coulter, Inc..
[2226941]
The customer reported that after several piercings during use onboard the act diff 2 hematology analyzer, one vial of 4c plus cell control leaked inside its packaging while being stored between use in the refrigerator. The operator was wearing personal protective equipment (lab coat, gloves and eye protection) at the time of the incident and there was no exposure of potentially biohazardous material to mucous membranes or open lesions. The operator did not s eek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[9369996]
This reportable event was identified during a retrospective review conducted for the period between (b)(4) 2008 and (b)(4) 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 leaky vial is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01998 |
| MDR Report Key | 2320296 |
| Report Source | 05,06 |
| Date Received | 2011-10-28 |
| Date of Report | 2009-06-16 |
| Date of Event | 2009-06-16 |
| Date Mfgr Received | 2009-06-16 |
| Date Added to Maude | 2011-12-19 |
| 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 | 7547114 |
| Lot Number | 1000241K |
| 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 |