MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-23 for HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL QCACT manufactured by International Technidyne Corp..
[20779122]
Healthcare professional reported that an end user sustained a needle stick while dispensing the product. A nurse was dispensing hemochron control plasma into a hemochron tube when the puncture injury occurred to the left index finger. The end user was wearing gloves at the time. The nurse sought medical attention and was evaluated by the employee health physician. No significant blood loss occurred. No complications or other related medical issues were reported.
Patient Sequence No: 1, Text Type: D, B5
[21041503]
This mdr submitted on 06/23/2015 references (b)(4). Method: actual device not evaluated. Process evaluation was not performed as the complaint is not related to product performance or packaging. Result: no results available since no evaluation performed. Conclusion: human factors issue. Training deficiency. Device not returned. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00006 |
| MDR Report Key | 4868081 |
| Report Source | 05 |
| Date Received | 2015-06-23 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2015-06-08 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-06-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JON MCDERMED |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2015-06-23 |
| Model Number | QCACT |
| Catalog Number | QCACT |
| Lot Number | K4TCA018 |
| Device Expiration Date | 2015-09-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-23 |