MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-12 for DIRECT CHECK QUALITY CONTROL DCPRO-A manufactured by International Technidyne Corp..
[2999757]
Healthcare professional reports end user was injured while activating the directcheck quality control. Customer noted she was training her staff members on how to use the directcheck controls and one person crushed the control vial until the glass came through the protective sleeve and stuck the user. There was no report of serious injury or administration of medical treatment.
Patient Sequence No: 1, Text Type: D, B5
[10348097]
(b)(4). A capa was completed for directcheck starting with lots manufactured in june 2011. Each directcheck package includes an insert containing a picture demonstrating the preferred technique to use during activation of the directcheck assembly. In addition, the itc website includes a video which illustrates the preferred technique to use during activation of the directcheck assembly. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2012-00010 |
| MDR Report Key | 2852163 |
| Report Source | 06 |
| Date Received | 2012-11-12 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-10-16 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2013-02-20 |
| 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 | 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 | DIRECT CHECK QUALITY CONTROL |
| Product Code | GGN |
| Date Received | 2012-11-12 |
| Model Number | DCPRO-A |
| Catalog Number | DCPRO-A |
| Lot Number | D1DAP013-P5 |
| Device Expiration Date | 2012-08-01 |
| 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 | 2012-11-12 |