MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2012-06-02 for VIGIL TDM CONTROL LEVEL 3 472472 manufactured by Beckman Coulter, Inc..
[20088516]
On (b)(6) 2012 beckman coulter warehouse in (b)(4) reported that they received a kit of therapeutic drug monitoring (tdm) controls that leaked due to loose caps. The control does contain material of human origin and should be considered potentially infectious. No injuries or exposure were reported.
Patient Sequence No: 1, Text Type: D, B5
[20213018]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01200 |
| MDR Report Key | 2596660 |
| Report Source | 00,01,07 |
| Date Received | 2012-06-02 |
| Date of Report | 2012-05-09 |
| Date of Event | 2012-05-09 |
| Date Mfgr Received | 2012-05-09 |
| Date Added to Maude | 2012-10-03 |
| 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 | VIGIL TDM CONTROL LEVEL 3 |
| Generic Name | DRUG MIXTURE CONTROL MATERIALS |
| Product Code | DIF |
| Date Received | 2012-06-02 |
| Catalog Number | 472472 |
| Lot Number | M107063 |
| Device Expiration Date | 2013-08-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-06-02 |