MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-08-26 for COULTER ACT 5DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[2195223]
Customer reported potential biohazard when the mid-level control vial of the coulter act 5diff control plus kit was found leaking. The leak was identified when the kit was opened. The customer stated that the cap of the vial was loose and the vial was almost empty. There was no exposure to open lesions or mucous membranes. The customer was wearing lab coat and gloves. There was no medical treatment 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
[9329311]
Product labeling states: "beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer. " product was not returned for eval. Root cause was not determined. Product labeling contains sufficient warnings/precautions for potential biohazard events. This reportable event was identified during a retrospective review conducted between (b)(4), 2008 and (b)(4), 2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01277 |
| MDR Report Key | 2259962 |
| Report Source | 01,05,06 |
| Date Received | 2011-08-26 |
| Date of Report | 2010-05-12 |
| Date of Event | 2010-05-12 |
| Date Mfgr Received | 2010-05-12 |
| Date Added to Maude | 2012-06-22 |
| 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 | COULTER ACT 5DIFF CONTROL PLUS |
| Product Code | JPK |
| Date Received | 2011-08-26 |
| Model Number | NA |
| Catalog Number | 7547198 |
| Lot Number | 0510 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-08-26 |