MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-12 for DIRECTCHECK QUALITY CONTROL DCJLR-A manufactured by International Technidyne Corp..
[4275195]
Healthcare professional reports an end user was punctured on his right pointer finger, distal joint when squeezing the directcheck quality control vial. The end user was not using the protective sleeve and was not wearing gloves at the time of the incident. The affected area was allowed to bleed and was cleaned with soap and water. There was no report of serious injury or administration of medical treatment. Per follow-up communication, the end user advised the affected area has healed.
Patient Sequence No: 1, Text Type: D, B5
[11811445]
This mdr submitted (b)(4) 2014 references itc complaint #(b)(4). Method: device history records reviewed and fond to meet release specifications. No related ncrs or current complaint trends identified. Conclusion: end user was not using the protective sleeve at the time of the injury. The directcheck protective sleeve is provided as a means to reduce probability of cuts. The instructions for use indicates use of protective sleeve is required when control vials are activated. Each package includes an insert containing a picture demonstrating the preferred technique to use during activation of the assembly. In addition, the itc website includes a video which illustrates the preferred technique to use during activation. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2014-00002 |
| MDR Report Key | 3739224 |
| Report Source | 05,06 |
| Date Received | 2014-03-12 |
| Date of Report | 2014-02-14 |
| Date Mfgr Received | 2014-02-14 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2014-05-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR FOX |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| 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 | 2014-03-12 |
| Catalog Number | DCJLR-A |
| Lot Number | L3DLA044 |
| Device Expiration Date | 2015-03-30 |
| 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 | 2014-03-12 |