MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-04 for TOBRAMYCIN REAGENT TEST KIT TOB REAGENT 467983 manufactured by Beckman Coulter, Inc..
[14923792]
Customer called to report that the contents of compartment c of tobramycin (lot #m106399) reagent was emptied, and that the top was not sealed. Customer stated that the reagent vessel would be disposed of according to proper laboratory procedures. Customer stated that approximately 3 milliliters of the reagent had leaked. Customer stated that the reagent was not installed into the system; therefore, patient data was not affected. 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
[15271888]
Customer requested and was sent a replacement reagent kit. Customer did not state damage to the other compartments within the shipment. Customer has not called back to report any further issues or harm by exposure as a result of the leak. (b)(4). Eval summary : shipment damage determined via telephone.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00843 |
| MDR Report Key | 2515919 |
| Report Source | 05,06 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-03-15 |
| Date of Event | 2012-03-15 |
| Date Mfgr Received | 2012-03-15 |
| Device Manufacturer Date | 2011-07-21 |
| Date Added to Maude | 2012-09-07 |
| 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 | TOBRAMYCIN REAGENT TEST KIT |
| Generic Name | FLUORESCENT IMMUNOASSAY, TOBRAMYCIN |
| Product Code | LCR |
| Date Received | 2012-04-04 |
| Model Number | TOB REAGENT |
| Catalog Number | 467983 |
| Lot Number | M106399 |
| Device Expiration Date | 2013-07-31 |
| 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 BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-04 |