MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-08 for ACT VIALED WHOLE BLOOD CONTROL QCACT manufactured by Accriva Diagnostics.
[101958991]
(b)(4). The lot number provided by the customer was not valid. Therefore, the date of manufacture, lot number and expiry date are unknown. Process evaluation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[101958992]
Occupational health nurse reported a needle stick injury sustained by an end user performing qc testing with a hemochron 801 act tube coagulation system. While withdrawing the qc material from the qcact vial, the needle slipped and punctured the end user's middle finger on her left hand. The end user squeezed the involved body part and washed it with soap and water three times. The end user also applied providone iodine. No additional management was administered by the occupational health nurse.
Patient Sequence No: 1, Text Type: D, B5
[108517083]
Lot number e7tca004.
Patient Sequence No: 1, Text Type: N, H10
[108517084]
Follow-up #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2018-00005 |
| MDR Report Key | 7325813 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-08 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-03-08 |
| 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 | ACT VIALED WHOLE BLOOD CONTROL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2018-03-08 |
| Model Number | QCACT |
| Catalog Number | QCACT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-03-08 |