MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-28 for COULTER 4C PLUS CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[2296886]
The customer noticed that the 4c plus normal control cap was off kilter and tried to fix it when the top of the tube broke. The tube top broke but no control material was spilled and no one was cut or otherwise injured. The 4c plus normal control is used in association with the act diff hematology analyzer. The operator was wearing gloves, lab coat and glasses at the time of the event. There was no reported exposure to open lesions or mucous membranes. No one sought medical attention in association with this event.
Patient Sequence No: 1, Text Type: D, B5
[9370504]
This reportable event was identified during a retrospective review conducted for the period between january 1, 2008 and october 23, 2010 of complaints for additional reportable events. The 4c plus control was replaced. The root cause is unknown. Per beckman coulter inc labeling: because no test method can offer complete assurance that (b)(4), or other infectious agents are absent, this specimen/reagent should be handled at biosafety level 2, as recommended for any potentially infectious human serum or blood specimen in the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01963 |
| MDR Report Key | 2320313 |
| Report Source | 05,06 |
| Date Received | 2011-10-28 |
| Date of Report | 2009-11-11 |
| Date of Event | 2009-11-11 |
| Date Mfgr Received | 2009-11-11 |
| Date Added to Maude | 2012-07-10 |
| 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 4C PLUS CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-10-28 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 1000277K |
| ID Number | NA |
| 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 | 2011-10-28 |