MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-02-14 for GENESEARCH BREAST LYMPH NODE ASSAY 2900005 manufactured by Veridex Llc.
[780184]
Customer complaint about sprays of ethanol coming out of vacuum pump. Issue is sporadic. Customer empties the manifold after each run and nevertheless experience the issue. Customer says spray is blue colored and sometimes hot. Customer did not experience any injuries or burns. No medical treatment was required.
Patient Sequence No: 1, Text Type: D, B5
[8092377]
Vacuum pump and qiagan qiavac-24 plus are not a device (general lab equipment). Device did not malfunction. User set-up of vacuum and pump may not be correct. No medical injury or treatment. Labeling for device (warning and precaution #16) states: all personnel should follow universal precautions and use lab safety equipment (i. E. Safety glasses, lab coat, gloves). If available, a fume hood should be used for preparing sample preparation kit reagents, and a biosafety cabinet should be used for preparing/handling biological material if a hood is not available, consider using a face shield during the homogenization step.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004582358-2008-00001 |
| MDR Report Key | 998834 |
| Report Source | 99 |
| Date Received | 2008-02-14 |
| Date of Report | 2008-02-14 |
| Date of Event | 2008-01-18 |
| Date Mfgr Received | 2008-01-18 |
| Date Added to Maude | 2009-04-30 |
| 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 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9085415843 |
| Manufacturer G1 | VERIDEX, LLC |
| Manufacturer Street | 33 TECHNOLOGY DR. |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENESEARCH BREAST LYMPH NODE ASSAY |
| Generic Name | GENESEARCH SAMPLE PREPARATION KIT |
| Product Code | OCB |
| Date Received | 2008-02-14 |
| Model Number | NA |
| Catalog Number | 2900005 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERIDEX LLC |
| Manufacturer Address | WARREN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-14 |