MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-05-18 for PHENYTOIN REAGENT 469188 manufactured by Beckman Coulter Inc..
[21677492]
A customer contacted beckman coulter inc. (bci) to report a leaking phenytoin cartridge. The device was handled with gloves and discarded. No reports of death or injury have been reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[21745879]
The customer was sent a replacement. A clear root cause is unknown at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01605 |
| MDR Report Key | 2092769 |
| Report Source | 01,06 |
| Date Received | 2011-05-18 |
| Date of Report | 2011-04-19 |
| Date of Event | 2011-04-19 |
| Date Mfgr Received | 2011-04-19 |
| Device Manufacturer Date | 2010-07-20 |
| Date Added to Maude | 2012-02-13 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHENYTOIN REAGENT |
| Generic Name | TOBRAMYCIN TEST SYSTEM |
| Product Code | DID |
| Date Received | 2011-05-18 |
| Model Number | NA |
| Catalog Number | 469188 |
| Lot Number | M004662 |
| ID Number | NA |
| Device Expiration Date | 2012-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-18 |