MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-02 for HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMAL DCJCPT-A manufactured by Accriva Diagnostics.
[61402053]
This mdr submitted on (b)(6) 2016 references accriva diagnostics' complaint number (b)(4). Actual device not evaluated. No dhr review was required because the complaint is unrelated to product performance or packaging. (b)(4). No results available since no evaluation performed. (b)(4). Human factors issue. Training deficiency. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[61402054]
A healthcare professional reported that an end user sustained a laceration while dispensing a directcheck quality control for a hemochron signature elite and citrate pt microcoagulation 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 was using the protective sleeve provided with the product when reconstituting the control. She removed the protective sleeve, squeezed the vial to dispense the control and a glass shard protruded through the dropper vial piercing the skin of her right index finger. Minor bleeding occurred. The end user washed her hand with soap and water and applied a bandaid to the injured area. No significant blood loss or other medical complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2016-00016 |
| MDR Report Key | 6142730 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-02 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-25 |
| Date Mfgr Received | 2016-12-01 |
| Device Manufacturer Date | 2016-03-09 |
| Date Added to Maude | 2016-12-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2016-12-02 |
| Model Number | DCJCPT-A |
| Catalog Number | DCJCPT-A |
| Lot Number | H6DAC007 |
| Device Expiration Date | 2017-10-31 |
| 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 | 2016-12-02 |