MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-23 for COULTER ACT 5 DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[19204227]
The customer reported the vial of act 5diff control had a loose cap and leaked during shipment. The leak was contained within the packaging box. The control product consists of consists of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid. The operator was wearing personal protective equipment at the time of the incident and there was no spill on the floor or counter and no control material spilled on the operator. There was no exposure to mucous membranes or open lesions. The operator did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[19445364]
This reportable event was identified during a retrospective review conducted for the period between (b)(6) 2008 and (b)(6) 2010 of complaints for additional reportable events. Product was replaced at the time of event. Service was not dispatched. Based upon available information root cause is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01532 |
| MDR Report Key | 2276805 |
| Report Source | 05,06 |
| Date Received | 2011-09-23 |
| Date of Report | 2009-08-06 |
| Date of Event | 2009-08-06 |
| Date Mfgr Received | 2009-08-06 |
| Date Added to Maude | 2012-06-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | COULTER ACT 5 DIFF CONTROL PLUS |
| Product Code | JPK |
| Date Received | 2011-09-23 |
| Model Number | NA |
| Catalog Number | 7547198 |
| Lot Number | 370709 |
| ID Number | NA |
| Device Expiration Date | 2009-09-01 |
| 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 | 2011-09-23 |