MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-19 for COULTER ACT 5DIFF CONTROL PLUS 7547198 manufactured by Beckman Coulter, Inc..
[2163243]
Customer reported a potential biohazard when one vial of coulter act 5diff control plus was found to be leaking upon arrival. The operator was wearing appropriate personal protective equipment of gloves when opening the shipping box. It was noted that there was a blood spill inside the box of less than 3 ml. There was no exposure of mucous membranes or open lesions to the material. 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
[9352639]
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. A review for similar events was conducted. There has been only one incident for receipt of leaking control plus vials in the past 12 months. 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 add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01205 |
| MDR Report Key | 2256760 |
| Report Source | 05,06 |
| Date Received | 2011-08-19 |
| Date of Report | 2010-04-23 |
| Date of Event | 2010-04-23 |
| Date Mfgr Received | 2010-04-23 |
| Date Added to Maude | 2012-06-21 |
| 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 | COULTER ACT 5DIFF CONTROL PLUS |
| Product Code | JPK |
| Date Received | 2011-08-19 |
| Model Number | NA |
| Catalog Number | 7547198 |
| Lot Number | 360510 |
| ID Number | NA |
| Device Expiration Date | 2010-07-05 |
| 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 AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-19 |