MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-10 for HEPCHECK P214 NORMAL CONTROL DCP214-N manufactured by Accriva Diagnostics.
[51837494]
(b)(4). Actual device not evaluated. No dhr review was required because the complaint is unrelated to product performance or packaging. No results available since no evaluation performed. Human factors issue. Device not returned. Accriva has requested all data required to complete form fda 3500a.
Patient Sequence No: 1, Text Type: N, H10
[51837495]
A healthcare professional reported that she sustained a cut to her right middle finger while dispensing a directcheck quality control for a hemochron response and act coagulation system. This control is packaged in a glass ampule contained within a crushable plastic dropper vial containing diluent. The end-user was wearing gloves and when reconstituting the product had used the protective sleeve provided with the product. The injury was caused by a glass shard that protruded through the dropper vial when the control was being dispensed. The end user had removed the protective sleeve before squeezing the tube. No significant blood loss occurred. The end user washed her hand and applied a bandage. No other medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00010 |
| MDR Report Key | 5867272 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-10 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-08-09 |
| Device Manufacturer Date | 2016-04-23 |
| Date Added to Maude | 2016-08-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JON MCDERMED |
| Manufacturer Street | 6260 SEQUENCE DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEPCHECK P214 NORMAL CONTROL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2016-08-10 |
| Model Number | DCP214-N |
| Catalog Number | DCP214-N |
| Lot Number | D6DHN002 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCRIVA DIAGNOSTICS |
| Manufacturer Address | 6260 SEQUENCE DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-10 |