MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-06-20 for VERIFYNOW P2Y12 TEST DEVICE 85064 manufactured by Accumetrics.
[2825598]
Finger stick to an exposed verifynow test device needle. After testing the tech initially threw out the intact vacutainer/test device into the medical waste container per the package insert instructions. Later in an attempt to resolve a test discrepancy, tech retrieved the intact test device / vacutainer from the medical west container and removed the vacutainer from the test device. After the tech removed the vacutainer from the test device and resolved the discrepancy, the tech went to throw out the separated test device and vacutainer and inadvertently inserted a finger into the sample well of the test device where the needle is housed. Device needle exposure (finger stick) occurred after tech removed sample vacutainer vial from device sample well. Wound was treated by thorough cleaning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031760-2012-00001 |
| MDR Report Key | 2640626 |
| Report Source | 05,06 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-06-20 |
| Date of Event | 2012-04-12 |
| Date Mfgr Received | 2012-06-11 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2012-08-07 |
| 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 Street | 3985 SORRENTO VALLEY BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8586431600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERIFYNOW P2Y12 TEST DEVICE |
| Product Code | JOZ |
| Date Received | 2012-06-20 |
| Catalog Number | 85064 |
| Lot Number | WL0113 |
| Device Expiration Date | 2013-09-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUMETRICS |
| Manufacturer Address | 3985 SORRENTO VALLEY BLVD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-06-20 |