MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-22 for 4C -ES CELL CONTROL 7547190 manufactured by Beckman Coulter, Inc..
[2128091]
Customer reported a potential biohazard when the vial of normal control from the 4c -es cell control kit fell and broke while preparing the control to be analyzed on the coulter act diff analyzer. The operator was wearing personal protective equipment (lab coat, gloves and eye protection) at the time of the incident and there was no exposure to mucous membranes or open lesions. The operator did not seek medical attention. The spill was cleaned up with bleach and disposed of in a biohazard container. 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
[9279026]
A review for similar complaints was conducted and found 4 additional reports of vials breaking from being dropped by customers from 2005 to january 2010. Based upon available info, root cause is the customer dropped the control bottle and the bottle broke. This reportable event was identified during a retrospective review conducted between 01/01/2008 and 10/23/2010 of complaints for additional reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00948 |
| MDR Report Key | 2185188 |
| Report Source | 05,06 |
| Date Received | 2011-07-22 |
| Date of Report | 2010-01-12 |
| Date of Event | 2010-01-12 |
| Date Mfgr Received | 2010-01-12 |
| Date Added to Maude | 2012-06-15 |
| 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 S.W. 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 -ES CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-07-22 |
| Model Number | NA |
| Catalog Number | 7547190 |
| Lot Number | 1655180K |
| ID Number | NA |
| Device Expiration Date | 2010-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 S.W. 147TH AVE. MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-22 |