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..
[2128579]
Customer reported a potential chemical hazard when a shipment of act 5diff wbc lyse reagent was received partially frozen and leaking from the cap area. The leak was small, less than 5 ml. The operators were not exposed to the reagent. There was no exposure to open lesions, mucus membranes, or any contact to eyes or skin. The operator was wearing proper 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
[9279027]
The customer discarded the leaking reagent bottles and were not returned for eval. Root cause is unk. This reportable event was identified during a retrospective review conducted between 01/01/2008 and 10/23/2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00964 |
| MDR Report Key | 2185190 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2010-01-20 |
| Date of Event | 2010-01-20 |
| Date Mfgr Received | 2010-01-20 |
| Device Manufacturer Date | 2009-10-22 |
| Date Added to Maude | 2012-06-12 |
| 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 S.W. 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 | 13202B00665 |
| ID Number | NA |
| Device Expiration Date | 2010-10-22 |
| 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 S.W. 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-22 |