MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-08-04 for CELLSEARCH CIRCULATING TUMOR CELL KIT 7900003 manufactured by Veridex Llc.
[905047]
Customer, lead research technician, reported on behalf of a colleague that has been exposed via splash to the eye with the ctc (circulating tumor cell) control cell in the 3ml vials. Customer reports that the user was in the process of transferring the control cells (b) (4) from the 3ml vial to a conical tube. A droplet of the control cell had splashed in the user's eye. Customer reports that the user did have protective personal protection, lab gown, gloves and safety goggles. Customer reported that the droplet may have traveled around the safety goggles. The customer reports that the msds (material safety data sheet) of the control kit was retrieved off of the veridex website and the user immediately rinsed their eyes with plenty of water for 15 min. At the time of the initial complaint, the customer did not seek any medical attention. Customer has contacted cts to obtain any additional info regarding the risk assessment to the exposure of the cells themselves in the kit, such as vial exposure.
Patient Sequence No: 1, Text Type: D, B5
[8105056]
Cts followed up with the customer and provided them with product details. Customer satisfied and has agreed to contact cts in the event of any additional information is required. The info provided to the customer was the following: the donors are tested for viral particulate contaminants and were all confirmed to be negative. There is literature that supports the fixation process these cells go through should potentially remove any possible viral transmission agents. While the risk is very low, there is no data on specific viruses or prions, so total safety cannot be assured. Therefore it is still recommend universal precautions with this product. Cts again referred the customer to the msds sheet to the control kit which indicates, "no known test method can offer complete assurance that products derived from human blood will not transmit infection agents. " the risk for blood borne disease is extremely low. The control cells contains 0. 1% sodium azide. The health hazard info posted in the msds sheet for the product has been labeled as a severity of 1 which is considered a slight hazard. Customer received medical attention, which included a hepatitis b vaccine injection. The incident was reported to their facilities' exposure control department.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004582358-2008-00004 |
| MDR Report Key | 1099508 |
| Report Source | 06 |
| Date Received | 2008-08-04 |
| Date of Report | 2008-08-05 |
| Date of Event | 2008-07-16 |
| Date Mfgr Received | 2008-07-16 |
| Date Added to Maude | 2010-04-07 |
| 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 | DEBRA RESMUSSEN |
| Manufacturer Street | 1001 HS HWY ROUTE 202 NORTH |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9085415483 |
| Manufacturer G1 | VERIDEX LLC |
| Manufacturer Street | 100 US HWY ROUTE 202 NORTH |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLSEARCH CIRCULATING TUMOR CELL KIT |
| Generic Name | CELLSEARCH CTC KIT |
| Product Code | NQI |
| Date Received | 2008-08-04 |
| Model Number | NA |
| Catalog Number | 7900003 |
| Lot Number | B086 |
| ID Number | NA |
| Device Expiration Date | 2009-03-17 |
| 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 | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-04 |