MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-24 for 4C PLUS COULTER CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[2135134]
Customer reported a potential hazard when a piece of glass broke off the rim of a vial of 4c plus coulter cell control. The rim broke when the operator was removing the cap. The operator was wearing personal protective equipment and there was no injury or exposure to mucous membranes or open wounds. 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
[9208107]
The two remaining controls within the kit did not exhibit this issue. The product was discarded by the customer and therefore not available for evaluation. There have been no similar events 12 months prior to this event. Root cause could not be determined. 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 | 1061932-2011-00686 |
| MDR Report Key | 2172317 |
| Report Source | 05,06 |
| Date Received | 2011-06-24 |
| Date of Report | 2008-01-09 |
| Date of Event | 2008-01-09 |
| Date Mfgr Received | 2008-01-09 |
| Date Added to Maude | 2012-05-02 |
| 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 | 4C PLUS COULTER CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-06-24 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 1000093K |
| ID Number | NA |
| Device Expiration Date | 2008-02-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-06-24 |