MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-27 for SYNCHRON? LX CO2 ACID REAGENT 472481 manufactured by Beckman Coulter, Inc..
[21783222]
A customer contacted beckman coulter inc. (bci) in regards to a spill from synchron lx co2 acid reagent. A technician was exposed to the spilled reagent. The technician flushed the exposed area with water and did not go to an emergency room. No injury was reported, and there was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[21821861]
The replacement reagent was sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-01707 |
| MDR Report Key | 1938237 |
| Report Source | 05 |
| Date Received | 2010-12-27 |
| Date of Report | 2010-12-01 |
| Date of Event | 2010-12-01 |
| Date Mfgr Received | 2010-12-01 |
| Device Manufacturer Date | 2010-10-29 |
| Date Added to Maude | 2012-01-23 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? LX CO2 ACID REAGENT |
| Generic Name | PH RATE MEASUREMENT, CARBON-DIOXIDE |
| Product Code | JFL |
| Date Received | 2010-12-27 |
| Model Number | NA |
| Catalog Number | 472481 |
| Lot Number | M010767 |
| Device Expiration Date | 2012-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-27 |