MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-26 for SYNCHRON SYSTEMS LIPID CALIBRATOR 650218 manufactured by Beckman Coulter, Inc..
[2728447]
The beckman coulter (bec) receiving warehouse reported that the lipid calibrator cartridge was leaking due to damage to the cartridge. The proper ppe (personal protective equipment) was used when handling the product. No one came in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed.
Patient Sequence No: 1, Text Type: D, B5
[10059396]
The damaged reagent cartridge was in the control and custody of the bec warehouse. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01316 |
| MDR Report Key | 2628399 |
| Report Source | 01,07 |
| Date Received | 2012-06-26 |
| Date of Report | 2012-05-29 |
| Date of Event | 2012-05-29 |
| Date Mfgr Received | 2012-05-29 |
| Device Manufacturer Date | 2011-08-09 |
| Date Added to Maude | 2012-10-16 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS LIPID CALIBRATOR |
| Generic Name | CALIBRATOR, PRIMARY |
| Product Code | JIS |
| Date Received | 2012-06-26 |
| Model Number | NA |
| Catalog Number | 650218 |
| Lot Number | M103070 |
| Device Expiration Date | 2012-10-31 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-26 |