MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-01 for SYNCHRON CX CO2 ACID REAGENT A17647 manufactured by Beckman Coulter, Inc..
[2418013]
On (b)(6) 2012 customer reported that they received a box of co2 acid containers that had leaked. Customer did not determine the cause of the leak. No injuries or exposure were reported. A replacement was sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
[9620265]
Device was not evaluated by manufacturer because the product was discarded by the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00357 |
| MDR Report Key | 2435483 |
| Report Source | 05,06 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-01-12 |
| Date of Event | 2012-01-12 |
| Date Mfgr Received | 2012-01-12 |
| Device Manufacturer Date | 2011-08-02 |
| Date Added to Maude | 2012-08-10 |
| 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 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX CO2 ACID REAGENT |
| Generic Name | PH RATE MEASUREMENT, CARBON-DIOXIDE |
| Product Code | CKA |
| Date Received | 2012-02-01 |
| Catalog Number | A17647 |
| Lot Number | 107156 |
| Device Expiration Date | 2013-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-02-01 |