MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for DIRECTCHECK QUALITY CONTROL DCJACT-N manufactured by Accriva Diagnostics.
[34922024]
(b)(4). Method: actual device not evaluated. Dhr review was not performed as the complaint is unrelated to product performance or packaging. Results: no results available since no evaluation performed. Conclusion: human factors issue. Training deficiency. Device not returned. Review of this case determined that the end user had not been fully trained on the proper method to crush the directcheck act plus normal control vial. Accriva diagnostics has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[34922105]
Healthcare professional reported that an end user punctured her finger while attempting to activate a directcheck act plus normal control. This control is packaged in a crushable vial containing a glass ampule. The end-user was wearing gloves, but was not utilizing the protective sleeve provided to safeguard against potential user injury during reconstitution. When crushing the vial, a glass shard protruded through the vial and caused the injury reported. No significant blood loss, complications or other medical issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002721930-2015-00010 |
| MDR Report Key | 5321414 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-03 |
| Date of Event | 2015-12-03 |
| Date Mfgr Received | 2015-12-03 |
| Device Manufacturer Date | 2015-03-10 |
| Date Added to Maude | 2015-12-22 |
| 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 | 0 |
| Brand Name | DIRECTCHECK QUALITY CONTROL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2015-12-22 |
| Model Number | DCJACT-N |
| Catalog Number | DCJACT-N |
| Lot Number | C5DNA007 |
| Device Expiration Date | 2016-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-12-22 |