MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-18 for DIRECTCHECK QUALITY CONTROL DCPRO-N manufactured by International Technidyne Corp..
[16799565]
End user reports she was injured on her right hand, middle digit from a piece of material that pierced through the direct-check quality control during activation of the control vial. End user 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 there were no signs of infection and the affected area is healing.
Patient Sequence No: 1, Text Type: D, B5
[17089317]
References itc complaint number (b)(4). Method: actual device not evaluated. Process evaluation performed. Device history records reviewed and found to meet release specifications. No related ncrs or current complaint trends identified. Result: no results available since no evaluation performed. Conclusion: human factors issue. End user was not using protective sleeve at the time of the injury. The direct-check 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. End user was re-educated on the preferred technique to use during activation of directcheck. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00009 |
| MDR Report Key | 3633908 |
| Report Source | 06 |
| Date Received | 2014-01-18 |
| Date of Report | 2013-11-19 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-11-19 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-04-21 |
| 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 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 | 2014-01-18 |
| Catalog Number | DCPRO-N |
| Lot Number | E3DCP005 |
| Device Expiration Date | 2014-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-01-18 |