MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-09-10 for IMMUNOPREP REAGENT 7546999 manufactured by Beckman Coulter, Inc..
[2243394]
A beckman coulter employee from a facility in (b)(6) reported receiving immunoprep reagent that was leaking due to loose caps. From the pictures attached to the complaint, the component that leaked was reagent a. The reporter of the incident reported wearing gloves after the leak was found. There was no exposure to open wounds or mucous membranes. Medical attention was not sought. There was no death, injury or change to patient treatment as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
[9288602]
Per labeling, warnings: #9. May cause sensitization by skin contact. #11. Wear suitable protective clothing, gloves and eye/face protection. #12. In case of accident or if you feel unwell, seek medical advice immediately. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01407 |
| MDR Report Key | 2242678 |
| Report Source | 01,07 |
| Date Received | 2011-09-10 |
| Date of Report | 2011-08-11 |
| Date of Event | 2011-08-11 |
| Date Mfgr Received | 2011-08-11 |
| Device Manufacturer Date | 2011-06-07 |
| Date Added to Maude | 2012-06-14 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNOPREP REAGENT |
| Generic Name | RED CELL LYSING REAGENT |
| Product Code | GGK |
| Date Received | 2011-09-10 |
| Catalog Number | 7546999 |
| Lot Number | 1099055K |
| Device Expiration Date | 2012-09-06 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-10 |