MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-15 for DRECTCHECK QUALITY CONTROL, NORMAL ACT+ DCJACT-N DCHACT-N manufactured by International Technidyne Corp..
[26192620]
This mdr submitted on 09/15/2015 references itc complaint number (b)(4). Method: actual device was not evaluated. Dhr review was not performed as the complaint is unrelated to product performance or packaging. No testing methods performed. Results: no results available since no evaluation performed. Conclusion: human factors issue. Training deficiency. Device not returned. Review of this case determined that the end user not been fully trained on the proper method to crush the directcheck control vial and administer the control. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
[26192621]
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 quality control is packaged in a glass ampule enclosed in a crushable vial. A protective sleeve is provided to protect the end user from injury. The end user crushed the vial to activate the control. She removed the sleeve to apply the control to the device's sample well and sustained a small cut to the second digit of her left hand by a shard of glass that penetrated the protective sleeve. The open wound drew some blood, so the end user squeezed her finger under running water and applied a sterile bandage. No significant blood loss occurred. The end user did not report any complications, wound infection or other medical issue related to the complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250033-2015-00008 |
| MDR Report Key | 5084097 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-15 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2015-08-27 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2015-09-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JON MCDERMED |
| Manufacturer Street | 8 OLSEN AVE. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal | 08820 |
| Manufacturer Phone | 8582632490 |
| Manufacturer G1 | INTERNATIONAL TECHNIDYNE CORP. |
| 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 | 0 |
| Brand Name | DRECTCHECK QUALITY CONTROL, NORMAL ACT+ |
| Product Code | GGN |
| Date Received | 2015-09-15 |
| Model Number | DCJACT-N |
| Catalog Number | DCHACT-N |
| Lot Number | D5DNA009 |
| Device Expiration Date | 2016-08-01 |
| 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 | 2015-09-15 |