MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-07 for COULTER BODY FLUID CONTROL 628030 manufactured by Beckman Coulter, Inc..
[2298269]
While evaluating an analyzer at the customer's laboratory, a beckman coulter, inc. (bec) applications specialist observed that one (1) of the four (4) coulter body fluid control vials had a pin hole on the bottom of the vial allowing the control fluid to leak out. The customer was not involved with this event. The leaking control vial was discovered by a bec applications specialist while conducting post-installation evaluation of the customer's analyzer. The bec applications specialist was wearing personal protective equipment (i. E. , lab coat and gloves) at the time of the event. There was no exposure to mucous membranes or open lesions. There was no report of death or serious injury associated with this event. Medical attention wa not sought. The material safety data sheet (msds) was not reviewed by the bec applications specialist at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[9372011]
The root cause of the pin hole in the control vial was not determined. Product labeling contains sufficient warnings/precautions addressing potential biohazard events. 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 | 1061932-2011-01652 |
| MDR Report Key | 2320081 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2009-06-22 |
| Date of Event | 2009-06-22 |
| Date Mfgr Received | 2009-06-22 |
| Date Added to Maude | 2011-12-13 |
| 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 BODY FLUID CONTROL |
| Product Code | JPK |
| Date Received | 2011-10-07 |
| Model Number | NA |
| Catalog Number | 628030 |
| Lot Number | 2461300K |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-10-07 |