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 2012-01-13 for SYNCHRON DRUG CALIBRATOR 1 469600 manufactured by Beckman Coulter, Inc..
[2566354]
On (b)(6) 2011 customer reported that they opened a new box of drug calibrator 1 and found that the level 6 vial had leaked during transit due to the cap being slightly loose. No injuries or exposure were reported. It was decided that an mdr should be filed for this event because drug calibrator 1 contains material of human origin, and upon recur, exposure is potentially infectious.
Patient Sequence No: 1, Text Type: D, B5
[9583439]
Beckman coulter identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00071 |
| MDR Report Key | 2416245 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-13 |
| Date of Report | 2011-12-23 |
| Date of Event | 2011-12-23 |
| Date Mfgr Received | 2011-12-23 |
| Device Manufacturer Date | 2011-04-05 |
| Date Added to Maude | 2012-08-03 |
| 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 DRUG CALIBRATOR 1 |
| Generic Name | CALIBRATORS, DRUG MIXTURE |
| Product Code | DKB |
| Date Received | 2012-01-13 |
| Catalog Number | 469600 |
| Lot Number | M011500 |
| Device Expiration Date | 2012-11-30 |
| 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 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-13 |