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 2012-04-26 for SYNCHRON DRUG CALIBRATOR 1 469600 manufactured by Beckman Coulter, Inc..
[2751931]
Customer called to report that small droplets of dried synchron drug calibrator 1, lot #m103090, were observed on the inside of the box and around the caps of some of the bottles. Customer did not come in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed. Customer was sent a replacement. The leakage was due too loose caps.
Patient Sequence No: 1, Text Type: D, B5
[9965133]
(b)(4). Reagent shipment not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01058 |
| MDR Report Key | 2551117 |
| Report Source | 01,05,06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-04-03 |
| Date Mfgr Received | 2012-04-13 |
| Device Manufacturer Date | 2011-10-07 |
| Date Added to Maude | 2012-09-14 |
| 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 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON DRUG CALIBRATOR 1 |
| Generic Name | CALIBRATORS, DRUG MIXTURE |
| Product Code | DKB |
| Date Received | 2012-04-26 |
| Model Number | NA |
| Catalog Number | 469600 |
| Lot Number | M103090 |
| Device Expiration Date | 2013-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-26 |