MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-23 for DIRECTCHECK QUALITY CONTROL DCJLR-N manufactured by International Technidyne Corp..
[5668326]
Healthcare professional reported that an injury occurred to an end user that was reconstituting a directcheck quality control. This control is packaged in a crushable vial. The end-user was wearing gloves, however, was not utilizing the protective sleeve provided to safeguard against potential user injury during reconstitution. End-user sustained a small laceration to the palm of her hand just below her thumb. No sterile bandage was required. The end user did not seek medical attention. No significant blood loss occurred. Per follow-up communication, the end user returned to work and is performing her usual duties. There were no complications or other related medical issues.
Patient Sequence No: 1, Text Type: D, B5
[13230937]
(b)(4). Actual device not evaluated. Dhr review was not performed as the complaint is unrelated to product performance or packaging. No testing methods performed. Review of this case determined that the end user had not been fully trained on the proper method to crush the directcheck pt normal control vial.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00004 |
| MDR Report Key | 4730043 |
| Report Source | 05 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-04-02 |
| Date Mfgr Received | 2015-04-02 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-06-05 |
| 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 | 8 OLSEN AVE |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| 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 |
| Generic Name | PLASMA, COAGULATION CONTROL |
| Product Code | GGN |
| Date Received | 2015-04-23 |
| Model Number | DCJLR-N |
| Catalog Number | DCJLR-N |
| Lot Number | A5DNL001 |
| Device Expiration Date | 2015-10-01 |
| 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 | 2015-04-23 |