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 2012-04-05 for SYNCHRON? SYSTEMS C-REACTVE PROTEIN (C-RP) REAGENT N/A 969620 manufactured by Beckman Coulter Inc..
[2574259]
The customer reported noticing a rupture on the neck of compartment b of a synchron systems c-reactve protein (c-rp) reagent. The customer was wearing personal protective equipment consisting of a lab coat, gloves and dioptric glasses during the event and there was no injury reported due to the exposure. The volume of the leak was reported to be about 50 ul.
Patient Sequence No: 1, Text Type: D, B5
[9892660]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00892 |
| MDR Report Key | 2519210 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-03-23 |
| Date of Event | 2012-03-23 |
| Date Mfgr Received | 2012-03-23 |
| Device Manufacturer Date | 2011-07-26 |
| Date Added to Maude | 2012-09-07 |
| 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 BOULEVARD |
| 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? SYSTEMS C-REACTVE PROTEIN (C-RP) REAGENT |
| Generic Name | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL |
| Product Code | DCK |
| Date Received | 2012-04-05 |
| Model Number | N/A |
| Catalog Number | 969620 |
| Lot Number | M108003 |
| Device Expiration Date | 2013-07-31 |
| 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 | 2012-04-05 |