MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-07-02 for IMMUNOPREP REAGENT SYSTEM, 300 TEST 7546999 manufactured by Beckman Coulter, Inc..
[2069676]
A customer reported to beckman coulter, inc (bec) that a shipment of immunoprep reagent arrived damaged and the reagent was leaking from all three reagents in the kit. The incident occurred in a beckman coulter warehouse. The operator was wearing lab coat, goggles, and gloves when handling the damaged containers. There was no exposure to open wounds or mucous membranes. The operator did not seek medical attention. The msds was reviewed and there is an exposure control plan in place at the facility. No death or injury occurred as a result of this incident and there was no change to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9280199]
The root cause for this event is damage to the package during shipping.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00825 |
| MDR Report Key | 2148254 |
| Report Source | 00,01 |
| Date Received | 2011-07-02 |
| Date of Report | 2011-06-02 |
| Date of Event | 2011-06-02 |
| Date Mfgr Received | 2011-06-02 |
| Device Manufacturer Date | 2011-04-06 |
| Date Added to Maude | 2012-05-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| 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 SYSTEM, 300 TEST |
| Generic Name | RED-CELL LYSING PRODUCTS |
| Product Code | GGK |
| Date Received | 2011-07-02 |
| Model Number | NA |
| Catalog Number | 7546999 |
| Lot Number | 1099052K |
| ID Number | NI |
| Device Expiration Date | 2012-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-07-02 |