MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-08-21 for IMMUNOPREP TM REAGENT (WHOLE BLOOD LYSING) SYSTEM IMMUNOPREP TM REAGENT SYSTEM 7546999 manufactured by Beckman Coulter Inc..
[2169164]
Beckman coulter inc (bec) (b)(4) reported receiving a shipment of retic prep reagent kits and immunoprep reagent kits and all of the bottles were wet. No visible damage due to shipping or loose caps. Per customer that the immunoprep reagent kit leaked, due to stains observed on the bottom of the immunoprep kit, and damaged the rest of the shipment. The customer turned the retic prep reagent kits over to verify that there was no leaks from those kits. The spill was contained and disposed of by the operator wearing ppe. No death or injury or change in patient treatment as a result of the incident. No exposure to open wounds or mucous membranes. The customer did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[9260841]
Service was not dispatched for this event. The root cause of the leak is unknown. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01247 |
| MDR Report Key | 2218035 |
| Report Source | 01,07 |
| Date Received | 2011-08-21 |
| Date of Report | 2011-07-21 |
| Date of Event | 2011-07-21 |
| Date Mfgr Received | 2011-07-21 |
| Device Manufacturer Date | 2011-05-18 |
| Date Added to Maude | 2012-06-21 |
| 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 BVLD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNOPREP TM REAGENT (WHOLE BLOOD LYSING) SYSTEM |
| Generic Name | RED CELL LYSING REAGENT. |
| Product Code | GGK |
| Date Received | 2011-08-21 |
| Model Number | IMMUNOPREP TM REAGENT SYSTEM |
| Catalog Number | 7546999 |
| Lot Number | 1099054K |
| ID Number | N/A |
| Device Expiration Date | 2012-08-09 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 11800 SW 147TH AVE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-21 |