MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-27 for DIRECTCHECK QUALITY CONTROL DCJLR-N manufactured by International Technidyne Corp..
[4345524]
Healthcare professional reports a nurse was injured on her left index finger from a piece of glass when activating the direct check quality control. The nurse was not using the protective sleeve at the time of the incident. She performed standard first aid to the affected area. No report of serious injury or administration of medical treatment. Customer advised the affected area is healing and there are no signs of infection.
Patient Sequence No: 1, Text Type: D, B5
[11639611]
(b)(4). Actual device not evaluated. Process eval performed. Device history records reviewed and found to meet release specifications. No related ncrs or current complaint trends identified. Human factors issue. End user was not using the protective sleeve at the time of the injury. The directcheck protective sleeve is provided as a means to reduce probability of cuts. The instructions for use indicates use of protective sleeve is required when control vials are activated. Each package includes an insert containing a picture demonstrating the preferred technique to use during activation of the assembly. In addition, the itc website includes a video which illustrates the preferred technique to use during activation of the assembly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00010 |
| MDR Report Key | 3669602 |
| Report Source | 06 |
| Date Received | 2013-12-27 |
| Date of Report | 2013-12-18 |
| Date of Event | 2013-12-14 |
| Date Mfgr Received | 2013-12-18 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-04-16 |
| 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 | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer G1 | INTERNATIONAL TECHNIDYNE CORP. |
| 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 | DIRECTCHECK QUALITY CONTROL |
| Product Code | GGN |
| Date Received | 2013-12-27 |
| Catalog Number | DCJLR-N |
| Lot Number | G3DNL028 |
| Device Expiration Date | 2014-03-31 |
| 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 | 23 NEVSKY ST. EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-27 |