MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-07-07 for SYNCHRON? ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT 467845 manufactured by Beckman Coulter, Inc..
[2093015]
A customer contacted beckman coulter inc (bci) in regards to a leak from a pack of synchron aspartate aminotransferase pyridoxal-5'-phosphase (ast) reagent cartridges. There was no exposure to uncovered wounds or mucous membranes. No injury was reported, and medical attention was not sought. Msds was reviewed and the customer has exposure control plan in the facility. There was no effect to patient or user.
Patient Sequence No: 1, Text Type: D, B5
[9139310]
The cap on the reagent cartridge was incorrectly screwed. The customer requested a replacement. The reagent kit was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02916 |
| MDR Report Key | 2152795 |
| Report Source | 01,06 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-06-09 |
| Date of Event | 2011-06-09 |
| Date Mfgr Received | 2011-06-09 |
| Device Manufacturer Date | 2011-02-02 |
| Date Added to Maude | 2012-03-20 |
| 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? ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT |
| Generic Name | ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE REAGENT |
| Product Code | CIT |
| Date Received | 2011-07-07 |
| Catalog Number | 467845 |
| Lot Number | M101633 |
| ID Number | NI |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-07-07 |