MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-03 for GENTAMICIN REAGENT TEST KIT GEN REAGENT 469137 manufactured by Beckman Coulter, Inc..
[2576474]
Customer called to report that approximately 20 milliliters of one gentamicin reagent cartridge, lot # m111207, was found leaking upon receipt of the ashes. Damage was found only to the internal kit, but not to the shipping box. The cause of the leak could not be determined. Customer was asked to empty the contents of the cartridge and to store the cartridge using proper laboratory procedures in the case that an investigation of the cartridge damage was necessary. Customer was wearing personal protective equipment (ppe) consisting of a laboratory coat and gloves. Customer did not come in contact with the fluid, and medical attention was not sought. There was no report of exposure to mucous membranes or open wounds, and no one was splashed or sprayed. There was no death, injury or change to patient treatment attributed to or associated with this complaint. There was no impact to patient samples or results.
Patient Sequence No: 1, Text Type: D, B5
[9708260]
Customer was offered a new reagent kit, but declined the offer. The other cartridge contained in the shipment was not damaged. Customer has not called back to report any further issues or harm by exposure as a result of the leak. (note: the beckman coulter, inc. Identifier for this report is (b)(4). Shipment damage determined via telephone
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00842 |
| MDR Report Key | 2515585 |
| Report Source | 05,06 |
| Date Received | 2012-04-03 |
| Date of Report | 2012-03-15 |
| Date of Event | 2012-03-15 |
| Date Mfgr Received | 2012-03-15 |
| Device Manufacturer Date | 2012-03-06 |
| Date Added to Maude | 2012-09-06 |
| 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 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTAMICIN REAGENT TEST KIT |
| Generic Name | ENZYME IMMUNOASSAY, GENTAMICIN |
| Product Code | LCD |
| Date Received | 2012-04-03 |
| Model Number | GEN REAGENT |
| Catalog Number | 469137 |
| Lot Number | M111207 |
| Device Expiration Date | 2014-03-31 |
| 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 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-03 |