MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-24 for ITC WHOLE BLOOD CONTROL QCACT manufactured by International Technidyne Corp..
[4888678]
Health professional reports end user injury while preparing the itc whole blood control. Health professional was adding diluent with a syringe to reconstitute the dried whole blood control material. When withdrawing the needle from the vial, health professional punctured her lateral palm of left hand with syringe. Health professional was wearing gloves at this time. The wound was cleansed with an antibacterial scrub. Itc whole blood control does not contain human blood products.
Patient Sequence No: 1, Text Type: D, B5
[12232842]
This mdr submitted on (b)(4) 2014 references itc complaint case (b)(4). No ncmrs identified. No related complaint trends or capas identified. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2014-00032 |
| MDR Report Key | 3993985 |
| Report Source | 05 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-06-25 |
| Date of Event | 2014-06-25 |
| Date Mfgr Received | 2014-06-25 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-08-18 |
| 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 | ELEANOR FOX |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 7325485700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITC WHOLE BLOOD CONTROL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2014-07-24 |
| Model Number | QCACT |
| Catalog Number | QCACT |
| Lot Number | C4TCA007 |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2014-07-24 |