MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-02-14 for IMMUNO-PREP REAGENT SYSTEM 7546999 manufactured by Beckman Coulter, Inc..
[21357692]
The beckman coulter, inc. Identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21419320]
A beckman coulter, inc. (bec) employee reported that bottle a of the immuno-prep reagent system reagent (300 test kit), lot #1099062k, leaked. The bec employee reported that there was neither slack of cap nor breakage of bottle, and that the package was intact. No service request was made since this was an internal complaint from a bec employee. The root cause of the leak is unknown. There was no report of death or injury and no one required medical attention. There was no report of exposure to open wounds or mucous membranes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2012-00505 |
| MDR Report Key | 2449367 |
| Report Source | 01,07 |
| Date Received | 2012-02-14 |
| Date of Report | 2012-01-18 |
| Date of Event | 2012-01-18 |
| Date Mfgr Received | 2012-01-18 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-08-16 |
| 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 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 11800 SW 147TH AVE. |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNO-PREP REAGENT SYSTEM |
| Generic Name | PRODUCTS, RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2012-02-14 |
| Model Number | IMMUNO-PREP REAGENT |
| Catalog Number | 7546999 |
| Lot Number | 1099062K |
| Device Expiration Date | 2013-02-22 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-14 |