MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-08-05 for ACT 5 DIFF FIX 8547171 manufactured by Beckman Coulter, Inc..
[2190888]
Beckman coulter, inc. Employee reported a potential chemical exposure when approx 20ml of fluid leaked from a container of act 5 diff fix reagent and two containers showed evidence of moisture. The warehouse employee was wearing gloves and work clothes at the time of the incident. There was no contact with mucous membranes or open wounds. No reports of death or serious injury, and no affect to operator safety treatment as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9403565]
Product was not returned for eval. Photographic images were sent. The photograph demonstrated indentation damage to the bottom of one of the containers. Root cause is unk. This reportable event was identified during a retrospective review of complaints conducted between (b)(6) 2008 and (b)(6) 2010 for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01067 |
| MDR Report Key | 2211530 |
| Report Source | 01,07 |
| Date Received | 2011-08-05 |
| Date of Report | 2010-03-03 |
| Date of Event | 2010-03-03 |
| Date Mfgr Received | 2010-03-03 |
| Date Added to Maude | 2012-06-20 |
| 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 SOUTH 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 5 DIFF FIX |
| Product Code | GGK |
| Date Received | 2011-08-05 |
| Model Number | NA |
| Catalog Number | 8547171 |
| Lot Number | 14802E |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-05 |