MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-16 for IGA REAGENT 446460 manufactured by Beckman Coulter Inc..
[1954416]
A customer contacted beckman coulter inc. (bci) to report iga reagent leaked while unloading shipping boxes. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9221791]
The leak was due to loose cap. Service was not dispatched. This is not a device issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00744 |
| MDR Report Key | 2020845 |
| Report Source | 06 |
| Date Received | 2011-03-16 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-02-14 |
| Date Mfgr Received | 2011-02-14 |
| Date Added to Maude | 2012-02-03 |
| 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 | 0 |
| 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 | 7149613436 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IGA REAGENT |
| Generic Name | IGA IMMUNOASSAY |
| Product Code | CZP |
| Date Received | 2011-03-16 |
| Model Number | IGA REAGENT |
| Catalog Number | 446460 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-03-16 |