MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-15 for ACT 5DIFF WBC LYSE 8547170 manufactured by Beckman Coulter, Inc..
[2141359]
Customer reported a potential hazard when the act 5diff wbc lyse reagent was leaking from the cap. There was no exposure to open lesions or mucous membranes. No contact to eyes or skin to the reagent. The operator was wearing appropriate personal protective equipment of lab coat and gloves. Medical attention was not required for this event. 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
[9137621]
The product was not returned for eval. The customer discarded the leaking reagent bottles. The root cause is unk. A review was conducted. There was only (b)(4) other similar report of reagent leaking upon delivery from 2004 to 2009. This reportable event was identified during a retrospective review conducted between (b)(4), 2008 and (b)(4), 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00869 |
| MDR Report Key | 2169814 |
| Report Source | 05,06 |
| Date Received | 2011-07-15 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-12-16 |
| Date Mfgr Received | 2009-12-16 |
| Date Added to Maude | 2012-05-25 |
| 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 AVENUE |
| 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 | 2011-07-15 |
| Model Number | NA |
| Catalog Number | 8547170 |
| Lot Number | 13202B07270 |
| ID Number | NA |
| Device Expiration Date | 2010-10-22 |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-15 |