MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for 4C PLUS COULTER CELL CONTROL 7547114 manufactured by Beckman Coulter, Inc..
[2137206]
Customer reported a minor injury when handling the abnormal control vial of the 4c plus coulter cell control. The vial broke when it slipped from the operator's fingers and fell on the floor. While removing the broken glass from the vial, the operator cut her finger on a sliver that penetrated her glove. The wound was cleaned per the laboratory's protocol and no further treatment was required. The operator was tested for infectious diseases per the laboratory's protocol. Testing was negative. 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
[9138671]
Product was not evaluated. A complaint review was conducted. There were no other reported events for 4c plus cell control vial with this issue within the past 12 months. Based on the info provided the root cause is mishandling of product. 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 | 1061932-2011-00789 |
| MDR Report Key | 2171216 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2008-04-04 |
| Date of Event | 2008-04-04 |
| Date Mfgr Received | 2008-04-04 |
| Device Manufacturer Date | 2008-03-10 |
| Date Added to Maude | 2012-05-04 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 7547114 |
| Lot Number | 085900 |
| ID Number | NA |
| Device Expiration Date | 2008-05-16 |
| 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 | 2011-07-01 |