MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-07-12 for SYNCHRON? CX TOTAL PROTEIN REAGENT 442740 manufactured by Beckman Coulter, Inc..
[18417887]
A customer reported to beckman coulter, inc. Of a leak from a bottle of synchron cx total protein reagent. There was no exposure to uncovered wounds or mucous membranes. No injury was reported, and medical attention was not sought. (b)(4) was reviewed and the facility has exposure control plan. There was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[18741331]
The crack at the bottom of the bottle caused the leakage. Photographs of damaged reagent kit were received. A replacement kit was sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02543 |
| MDR Report Key | 2158881 |
| Report Source | 00,01 |
| Date Received | 2011-07-12 |
| Date of Report | 2011-06-08 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-06-08 |
| Device Manufacturer Date | 2011-02-20 |
| Date Added to Maude | 2012-03-27 |
| 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 | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? CX TOTAL PROTEIN REAGENT |
| Generic Name | TOTAL PROTEIN TEST REAGENT |
| Product Code | CKA |
| Date Received | 2011-07-12 |
| Catalog Number | 442740 |
| Lot Number | Z102232 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-12 |