MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-15 for DIRECTCHECK QUALITY CONTROL DCJACT-N manufactured by International Technidyne Corp..
[6029185]
Healthcare professional reported that an injury occurred to an end user that was reconstituting a directcheck quality control for a hemochron signature elite and act microcoagulation system. This control is packaged in a glass ampoule enclosed in a crushable vial. When the end user crushed the vial to activate the control, a shard of glass penetrated his glove and punctured his left thumb. The end-user immediate sought medical attention for his thumb injury with employee health. The glass was removed from his thumb and a sterile bandage was applied. The end user returned to work. It is not clear whether or not the end user was wearing the protective sleeve provided by itc to safeguard against potential user injury during reconstitution of the control. No significant blood loss occurred. There were no complications or other related medical issues.
Patient Sequence No: 1, Text Type: D, B5
[14035114]
This mdr submitted on (b)(6) 2015 references itc complaint number # (b)(4). Method codes: 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 control vial. Itc continues to request clarification as to the lot number of the directcheck control used in this complaint. Itc has requested all data required for form 3500a. Fields for which data were not obtainable or are not applicable are intentionally left black:
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00007 |
| MDR Report Key | 4921129 |
| Report Source | 05 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-16 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-22 |
| 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 AVENUE |
| 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 | 2015-07-15 |
| Model Number | DCJACT-N |
| Catalog Number | DCJACT-N |
| Lot Number | C5DNA007 |
| Device Expiration Date | 2016-08-31 |
| 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 | 2015-07-15 |