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 2011-09-16 for COULTER 5C CELL CONTROL 7547124 manufactured by Beckman Coulter, Inc..
[2302994]
The customer reported that a single coulter 5c cell control vial leaked through the rubber stopper and plastic cap while on the analyzer's rocker bed. The potential for biohazard exposure with the reported incident was present. The operator was wearing personal protective equipment (ppe) at the time of the incident. There was no exposure to mucous membranes or open lesions. No injuries occurred and medical attention was not sought as a result of this event. The material safety data sheet (msds) was not reviewed; however, it is readily available. The lab's exposure control or risk management plans are in place. No reports of death or serious injury, and no affect to operator safety as a result of this event. The product was replaced at time of event.
Patient Sequence No: 1, Text Type: D, B5
[9350027]
Per labeling, beckman coulter, inc. Urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but it is not limited to, protective eyewear, gloves, and suitable lab attire when operating or maintaining this or any other automated lab analyzer. The field service engineer inspected the instrument and verified the instrument's operation. There were no anomalies noted. Based on available info, the root cause for the vial leaking is unk. This reportable event was identified during a retrospective review conducted between jan. 1, 2008 and oct. 23, 2010 of complaints for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01454 |
| MDR Report Key | 2267010 |
| Report Source | 01,05,06 |
| Date Received | 2011-09-16 |
| Date of Report | 2009-02-06 |
| Date of Event | 2009-02-05 |
| Date Mfgr Received | 2009-02-06 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2012-06-26 |
| 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 | COULTER 5C CELL CONTROL |
| Product Code | JPK |
| Date Received | 2011-09-16 |
| Model Number | NA |
| Catalog Number | 7547124 |
| Lot Number | 885500 |
| ID Number | NA |
| Device Expiration Date | 2009-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2011-09-16 |