MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-05 for ITC WHOLE BLOOD CONTROL QCACT manufactured by International Technidyne Corp..
[3155280]
Nurse reports end user injury while preparing the itc whole blood control. Nurse was adding diluent with a syringe to reconstitute the dried whole blood control material. When withdrawing the needle from the vial, she sustained a scratch on the ring finger of her left hand. Nurse was wearing gloves at this time. Nurse stated she did not bleed very much and washed her hands per the facility's procedures. The next morning, she noticed that the scratch was inflamed approximately 2cm across and went to the hospital to have it examined. At the hospital, she received a tetanus shot and was treated with antibiotics. Material safety data sheet provided to customer. Itc whole blood control does not contain human blood products.
Patient Sequence No: 1, Text Type: D, B5
[10441364]
(b)(4). Method - actual device not evaluated. Process evaluation performed. Device history record for control lot was reviewed. No ncmrs identified. No related complaint trends or capas identified. Result - no results available since no evaluation performed. Conclusion - known inherent risk of procedure. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00001 |
| MDR Report Key | 2948074 |
| Report Source | 06 |
| Date Received | 2013-02-05 |
| Date of Report | 2013-01-11 |
| Date of Event | 2013-01-10 |
| Date Mfgr Received | 2013-01-11 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-02-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE PICCIANO |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITC WHOLE BLOOD CONTROL |
| Product Code | GGN |
| Date Received | 2013-02-05 |
| Catalog Number | QCACT |
| Lot Number | K2WQC023 |
| Device Expiration Date | 2013-10-01 |
| 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 | 2013-02-05 |