MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-23 for TOB (TOBRAMYCIN) REAGENT 467983 manufactured by Beckman Coulter, Inc..
[21360876]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21460196]
On (b)(4) 2012, customer reported that they recieved a broken kit of tobramycin reagent. Customer stated that the cap on compartment c was broken. Customer stated was wearing lab coat and gloves when the kit was opened and no exposure/injuries occurred. A replacement kit was sent to customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2012-00543 |
| MDR Report Key | 2466534 |
| Report Source | 05,06 |
| Date Received | 2012-02-23 |
| Date of Report | 2012-02-03 |
| Date of Event | 2012-02-03 |
| Date Mfgr Received | 2012-02-03 |
| Device Manufacturer Date | 2011-07-13 |
| Date Added to Maude | 2012-08-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVE. |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOB (TOBRAMYCIN) REAGENT |
| Generic Name | FLUORESCENT IMMUNOASSAY, TOBRAMYCIN |
| Product Code | LCR |
| Date Received | 2012-02-23 |
| Catalog Number | 467983 |
| Lot Number | M102286 |
| Device Expiration Date | 2013-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-02-23 |