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 2012-06-06 for SYNCHRON? TRIGLYCERIDES 445850 manufactured by Beckman Coulter, Inc..
[2742034]
The affiliate reported the customer alleged the cartridge was damaged and leaked reagent fluid from the base during removal of the cartridge from the carton packaging involving synchron triglycerides. The customer had on personal protective equipment (ppe) consisting of protective clothing during the incident. The reagent was not loaded into the instrument. The customer did not have direct contact with the fluid. There was no exposure to open lesions or mucus membranes. There was no report of injury or adverse effect associated with this incident. The customer has an exposure control management plan at the facility.
Patient Sequence No: 1, Text Type: D, B5
[9828301]
A definitive cause of the incident is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01234 |
| MDR Report Key | 2600220 |
| Report Source | 01,05,06 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-14 |
| Date of Event | 2012-05-14 |
| Date Mfgr Received | 2012-05-14 |
| Device Manufacturer Date | 2011-11-03 |
| Date Added to Maude | 2012-10-05 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? TRIGLYCERIDES |
| Generic Name | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
| Product Code | CDT |
| Date Received | 2012-06-06 |
| Model Number | NA |
| Catalog Number | 445850 |
| Lot Number | T110119 |
| Device Expiration Date | 2013-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-06 |