MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-02 for COULTER? DIFF ACT TAINER 4L 8547135 manufactured by Beckman Coulter, Inc..
[15412091]
A customer reported that the entire content of reagent 3 shutdown diluent (ethylene oxide) in diff act tainer was leaking upon receiving. The customer also stated it appeared the cover was not on correctly, but no punctures were visible. The leak was contained in the box. The customer was wearing gloves at time of incident. No injuries occurred and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds. The material safety data sheet (msds) was reviewed. There was no death, injury attributed or connected with this complaint.
Patient Sequence No: 1, Text Type: D, B5
[15796713]
The product was replaced. The root cause was attributed to a loose cap on the reagent container.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-00826 |
| MDR Report Key | 2148272 |
| Report Source | 06 |
| Date Received | 2011-07-02 |
| Date of Report | 2011-06-03 |
| Date of Event | 2011-06-02 |
| Date Mfgr Received | 2011-06-03 |
| Device Manufacturer Date | 2011-04-11 |
| 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 | COULTER? DIFF ACT TAINER 4L |
| Generic Name | SHUTDOWN REAGENT |
| Product Code | GGK |
| Date Received | 2011-07-02 |
| Model Number | NA |
| Catalog Number | 8547135 |
| Lot Number | 115127K |
| ID Number | NA |
| Device Expiration Date | 2012-03-27 |
| 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 |