MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-20 for DIRECTCHECK QUALITY CONTROL DCJLR-N manufactured by International Technidyne Corp..
[5524512]
Healthcare professional reported that an unidentified end user sustained a superficial puncture wound to the skin of the finger when squeezing the directcheck act-lr normal quality control vial. The end user was not using the protective sleeve provided with the product to prevent potential injury when activating the control vial. The end use immediately washed the finger with soap and water and sought medical attention as per the hospital's standard operating procedure. No excessive bleeding occurred and no bandage was required. Per follow-up communication, the puncture wound has healed and the end user returned to work.
Patient Sequence No: 1, Text Type: D, B5
[13019375]
Reference itc complaint #(b)(4). The directcheck protective sleeve is provided as a means to reduce probability of lacerations. Healthcare professional stated that the employee was not fully trained on the operation of the instrument. The entire staff was retrained as to how to run the controls and requirement to use protective sleeve. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00001 |
| MDR Report Key | 4546856 |
| Report Source | 05,06 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-06 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-03-23 |
| 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 | JON MCDERMED |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTCHECK QUALITY CONTROL |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2015-02-20 |
| Model Number | DCJLR-N |
| Catalog Number | DCJLR-N |
| Lot Number | H4DNL039 |
| Device Expiration Date | 2015-05-31 |
| 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 | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-20 |