MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-10-12 for KIT NAOH-D/BASIC WASH 2 X 1.8L 04880285190 manufactured by Roche Diagnostics.
[15020239]
A customer received an injury when an open bottle of naoh-d fell from a table and splashed on her face. The employee rinsed her face with water immediately and was treated by the safety person of the hospital. This treatment included more washing and then treatment with burn ointment. The employee is now on sick leave with burn wounds between first and second degree. There was no damage to the employee's eyes although the employee wore no safety goggles. Upon follow up, it was confirmed the employee was "ok". The customer was refilling the bottle at the time of the event because the software of the analyzer, cobas 6000 c501 analyzer serial number (b)(4), indicated the bottle was empty. Refilling of reagent bottles is not recommended. The customer alleged an issue with the software, stating the system is alerting them that the volume of the reagent is zero, or empty, when there is still reagent left in the bottle. This issue was previously investigated and it was determined the system is functioning properly. The system alerts the user when the usable volume for the product has been reached. It is expected there will be 200 to 300 ml of liquid left in the bottle. Refilling of this bottle is not recommended. The customer also believed that an additional warning sentence should be included on the bottle itself. The labeling was investigated and determined to be in compliance with labeling regulations. The operator's manual for the analyzer and the package insert for naoh-d provide safety warnings for exchange of cell wash bottles. The labeling also includes a protective equipment warning and hazard labeling. The detergent compartment on the analyzer also includes a label with a protective equipment warning.
Patient Sequence No: 1, Text Type: D, B5
[15463857]
It was unknown if the initial reporter sent report to the fda. This event occurred in the (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-05113 |
| MDR Report Key | 2785262 |
| Report Source | 01,05,06 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-09-17 |
| Date Mfgr Received | 2012-09-18 |
| Date Added to Maude | 2012-10-12 |
| 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 | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT NAOH-D/BASIC WASH 2 X 1.8L |
| Generic Name | DETERGENT - GENERAL PURPOSE REAGENT |
| Product Code | JCB |
| Date Received | 2012-10-12 |
| Model Number | NA |
| Catalog Number | 04880285190 |
| Lot Number | 102175-64 |
| ID Number | NA |
| Device Expiration Date | 2014-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-12 |