MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-07-29 for ACT 5DIFF WBC LYSE 8547170 manufactured by Beckman Coulter, Inc..
[18841336]
Beckman coulter employee reported a potential chemical hazard when act 5diff wbc lyse reagent leaked. One bottle was found to have a small amount of fluid on the outside of the bottle. There was no exposure to the act 5diff wbc lyse reagent. There was no exposure to open lesions or mucus membranes. Warehouse worker was wearing appropriate personal protective equipment. Medical attention was not required. 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
[19043075]
Product was not returned for evaluation. Root cause is unk. The supplier was notified of the issue for further evaluation. This reportable event was identified during a retrospective review conducted between (b)(6), 2008 and (b)(6), 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01021 |
| MDR Report Key | 2188394 |
| Report Source | 01,07 |
| Date Received | 2011-07-29 |
| Date of Report | 2010-02-01 |
| Date of Event | 2010-02-01 |
| Date Mfgr Received | 2010-02-01 |
| Date Added to Maude | 2012-06-19 |
| 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 | ACT 5DIFF WBC LYSE |
| Product Code | GGK |
| Date Received | 2011-07-29 |
| Model Number | NA |
| Catalog Number | 8547170 |
| Lot Number | 12902B |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-07-29 |