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 2012-06-06 for VIGIL? TDM CONTROL 472472 manufactured by Beckman Coulter, Inc..
[2742525]
The affiliate reported the therapeutic drug monitoring (tdm) control reagent leaked upon receipt involving vigil tdm control. The affiliate indicated the reagent leaked due to a loose cap. The affiliate had on personal protective equipment (ppe) consisting of gloves and eye protection during the incident. Patient sample analysis was not involved. The affiliate did not have direct contact with the fluid. There was no exposure to open lesions or mucus membranes. There was no report of injury or adverse effect associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
[9828312]
A definitive cause of the incident is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-01233 |
| MDR Report Key | 2600242 |
| Report Source | 01,05,06 |
| Date Received | 2012-06-06 |
| Date of Report | 2012-05-16 |
| Date of Event | 2012-05-16 |
| Date Mfgr Received | 2012-05-16 |
| Device Manufacturer Date | 2011-08-03 |
| Date Added to Maude | 2012-10-04 |
| 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 | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIGIL? TDM CONTROL |
| Generic Name | DRUG MIXTURE CONTROL MATERIALS |
| Product Code | DIF |
| Date Received | 2012-06-06 |
| Model Number | NA |
| Catalog Number | 472472 |
| Lot Number | M107063 |
| Device Expiration Date | 2013-08-31 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-06 |