MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-22 for ACT 5DIFF WBC LYSE 8547170 manufactured by Beckman Coulter, Inc..
[2133078]
Customer reported a potential chemical hazard when act 5diff wbc lyse reagent leaked. A small amount had leaked from the cap and onto the side of the bottle. There was no exposure to the act 5diff wbc lyse reagent. There was no exposure to open lesions or mucus membranes. Operators were wearing appropriate personal protective equipment of lab coat and gloves. 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
[9273815]
The customer used lab protocol to clean the bottle for use. The product was not returned for eval. Root cause is unk. The supplier was notified of the issue for further eval. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00991 |
| MDR Report Key | 2185135 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2010-02-01 |
| Date of Event | 2010-01-29 |
| Date Mfgr Received | 2010-02-01 |
| Device Manufacturer Date | 2009-10-22 |
| Date Added to Maude | 2012-05-30 |
| 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 | ACT 5DIFF WBC LYSE |
| Product Code | GGK |
| Date Received | 2011-07-22 |
| Model Number | NA |
| Catalog Number | 8547170 |
| Lot Number | 13202B |
| ID Number | NA |
| Device Expiration Date | 2010-10-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-07-22 |