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 2012-03-07 for SYNCHRON SYSTEM DRUG CALIBRATOR 2 469630 manufactured by Beckman Coulter, Inc..
[2406751]
Customer reported to beckman coulter, inc. (bec) that they found the level 5 vial had leaked when they opened a new box of synchron system drug calibrator 2 to perform a calibration. Customer reported that the vial appeared to be damaged. Customer reported that the volume of the leak was approximately 2 ml. There was no report of erroneous results generated. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9674078]
Evaluation codes - results code - (other): vial. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9675853]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050010-2012-00012 |
| MDR Report Key | 2482758 |
| Report Source | 01,05,06 |
| Date Received | 2012-03-07 |
| Date of Report | 2012-02-11 |
| Date of Event | 2012-02-10 |
| Date Mfgr Received | 2012-02-11 |
| Device Manufacturer Date | 2011-04-25 |
| Date Added to Maude | 2012-08-27 |
| 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 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVENUE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEM DRUG CALIBRATOR 2 |
| Generic Name | CALIBRATORS, DRUG SPECIFIC |
| Product Code | DLJ |
| Date Received | 2012-03-07 |
| Model Number | DRUG CALIBRATOR 2 |
| Catalog Number | 469630 |
| Lot Number | NA |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 2470 FARADAY AVENUE CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-07 |