MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-22 for SYNCHRON LX CO2 ACID REAGENT 472481 manufactured by Beckman Coulter, Inc..
[2355343]
Customer reported to beckman coulter, inc. (bec) that they received leaking co2 reagent. Customer requested replacement. Customer reported that erroneous results were not generated or reported outside the laboratory. Customer reported that no individual was treated medically due to exposure. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9484675]
Bec is filing this report because co2 acid reagent is corrosive, may cause burns to the eyes, skin, respiratory tract and gastrointestinal tract. Strong inorganic acid mists containing sulfuric acid may cause cancer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07844 |
| MDR Report Key | 2346574 |
| Report Source | 05,06 |
| Date Received | 2011-11-22 |
| Date of Report | 2011-10-25 |
| Date of Event | 2011-10-25 |
| Date Mfgr Received | 2011-10-25 |
| Date Added to Maude | 2012-07-17 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 | 2011-11-22 |
| Catalog Number | 472481 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-22 |