MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-11 for CELLTRACKS AUTOPREP SYSTEM 9541 manufactured by Veridex, Llc.
[1051544]
A veridex employee indicated that when inverting a celltracks autoprep system waste bottle to empty it in the sink, the waste bottle ruptured and the waste and bleach sprayed all over his lab coat and his face. The employee was wearing goggles and did not get any liquid into his eyes, however, some liquid did enter his mouth. The waste bottle contained human blood, dilution buffer, reagents and clorox bleach. The total volume of liquid waste was approximately 4 litres and the capacity of the waste bottle is 5 litres. Approximately 0. 5l of the waste material projected onto the veridex employee. The veridex employee sought medical attention the same day.
Patient Sequence No: 1, Text Type: D, B5
[8253369]
The waste bottle is used with the celltracks autoprep system to collect the liquid waste (human blood, dilution buffer and reagents) generated during the celltracks sample preparation procedure. A 400ml of clorox bleach is added to the bottle to decontaminate the liquid waste generated during the celltracks autoprep procedure. The bleach is added to the bottle after it is emptied, and prior to the liquid waste being emptied into the waste bottle from the instrument. The human blood consists mainly of plasma. The veridex employee indicated that the celltracks autoprep system waste bottles are used interchangeably among the 5 systems installed at their site. There is one waste bottle for each instrument. The employee does not remember which instrument the waste bottle was associated with at the time the event occurred. The oldest autoprep system installed at this veridex site was shipped to the site in 2003. The veridex employee visited his dr the same day the event occurred and received an (b)(6) and (b)(6) as a preventive measure. The employee has not experienced any skin irritation, vomiting or dizziness and has not experienced any health issues since the event occurred. The waste bottle involved in this event has been returned to veridex llc, (b)(4), and a failure investigation is underway. In addition, a customer letter is being sent to all customers. This letter instructs customers to inspect the bottles on their celltracks autoprep system during the daily cleaning procedure and to not use cracked or damaged waste bottles. Veridex will replace cracked or damaged bottles.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004582358-2009-00001 |
| MDR Report Key | 1342099 |
| Report Source | 07 |
| Date Received | 2009-03-11 |
| Date of Report | 2009-02-26 |
| Date of Event | 2009-02-20 |
| Date Mfgr Received | 2009-02-26 |
| Date Added to Maude | 2010-08-27 |
| 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 | DEBRA RASMUSSEN |
| Manufacturer Street | 1001 US HWY 202 N |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9085415483 |
| Manufacturer G1 | VERIDEX LLC |
| Manufacturer Street | 3401 MASONS MILL RD STE 100 |
| Manufacturer City | HUNTINGDON VALLEY PA 19006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19006 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLTRACKS AUTOPREP SYSTEM |
| Generic Name | CELLTRACKS AUTOPREP SYSTEM |
| Product Code | GKH |
| Date Received | 2009-03-11 |
| Returned To Mfg | 2009-03-10 |
| Model Number | NA |
| Catalog Number | 9541 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERIDEX, LLC |
| Manufacturer Address | RARITAN NJ 08869 US 08869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-11 |