MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-11 for DIRECTCHECK QUALITY CONTROL DCJACT-N manufactured by International Technidyne Corp..
[5946779]
Healthcare professional reported that an injury occurred to an end user who was preparing to discard a used directcheck quality control, which is packaged in a crushable vial. End user was wearing gloves. While removing the protective sleeve provided to safeguard against potential injury during use of the device, end user discovered crushed glass shards lodged in the sleeve. End user's right thumb was punctured by a shard of glass while attempting to remove it. End use washed their hands immediately and sought medical attention. No significant blood loss occurred. No complications or other related medical issues were reported.
Patient Sequence No: 1, Text Type: D, B5
[13492829]
(b)(4). Process evaluation was not performed as the complaint is not related to product performance or packaging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00005 |
| MDR Report Key | 4844604 |
| Report Source | 05 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-06-04 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-04 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-06-25 |
| 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 | 2015-06-11 |
| Model Number | DCJACT-N |
| Catalog Number | DCJACT-N |
| Lot Number | C5DNA007 |
| Device Expiration Date | 2016-08-01 |
| 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 | 2015-06-11 |