MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-05 for SYNCHRON SYSTEMS DRUG CALIBRATOR 2 469630 manufactured by Beckman Coulter, Inc..
[17559835]
On (b)(4) 2012, customer reported that they received a vial of drug calibrator 5 that had leaked in the box. No injury was reported due to the exposure. Replacement was sent overnight. It was determined that an mdr should be filed because the product contains material of human origin and upon recur, unprotected contact with the product is potentially infectious, and could cause serious injury.
Patient Sequence No: 1, Text Type: D, B5
[17707031]
Device evaluated by manufacturer, other: customer discarded the reagent. (b)(4). Other text: product discarded by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00650 |
| MDR Report Key | 2478719 |
| Report Source | 05,06 |
| Date Received | 2012-03-05 |
| Date of Report | 2012-02-16 |
| Date of Event | 2012-02-16 |
| Date Mfgr Received | 2012-02-16 |
| 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 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVE. |
| 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 SYSTEMS DRUG CALIBRATOR 2 |
| Generic Name | CALIBRATORS, DRUG SPECIFIC |
| Product Code | DLJ |
| Date Received | 2012-03-05 |
| Catalog Number | 469630 |
| Lot Number | M101710 |
| Device Expiration Date | 2013-04-30 |
| 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 | 2012-03-05 |