MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-03 for DIRECTCHECK QUALITY CONTROL DCJLR-A manufactured by International Technidyne Corp..
[18092485]
Healthcare professional reported that an injury occurred to a quality control technologist during reconstitution of a directcheck quality control. This control is package in a crushable vial. The end-user was wearing gloves and was utilizing the protective sleeve provided to safeguard against potential user injury during reconstitution. End-user sustained a small cut to the upper portion of the left thumb, which was caused by a glass shard protruding through the protective sleeve. The thumb was washed with soap and water, sanitized with alcohol and covered with a sterile bandage. The end user did not seek further medical attention. No significant blood loss occurred. Per follow-up communication, the puncture wound healed and the end user returned to work. There were no complications or other related medical issues.
Patient Sequence No: 1, Text Type: D, B5
[18559286]
(b)(4). Method: dhr review was not performed as the complaint is unrelated to product performance or packaging. Conclusion: human factors issue. Training deficiency, device not returned. Review of this case determined that the end user had not been fully trained on the proper method to crush the direct check pt abnormal control vial.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00003 |
| MDR Report Key | 4665305 |
| Report Source | 05,06 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-27 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-03-27 |
| Date Added to Maude | 2015-05-14 |
| 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 | 2015-04-03 |
| Model Number | DCJLR-A |
| Catalog Number | DCJLR-A |
| Lot Number | K3DLA042 |
| 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 | 2015-04-03 |