MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-18 for DIRECTCHECK QUALITY CONTROL DCJCPT-A manufactured by International Technidyne Corp..
[5695564]
Healthcare professional reported an injury to an end user that happened during reconstruction of a directcheck hemochron jr. Abnormal control packaged in a crushable vial. End user was wearing gloves but did not use the protective sleeve provided to safeguard against possible injury when reconstituting the product. End user sustained a cut to the thumb, which was washed with soap and water, sanitized with alcohol and covered with a sterile bandage. End user did not seek further medical attention; hospital policy only applies to needle sticks. Per policy, the decision whether or not to seek further medical attention was left to the end user. 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
[13084159]
(b)(4). Method - actual device not evaluated. Dhr review was not performed as the complaint is unrelated to product performance or packaging. Product was not inspected or tested because the end user did not use the protective sleeve as indicated in the apckage insert. Results - no results available since no evaluation performed. Conclusion: human factors issue. Training deficiency. Review of this case determined that the end user had not been fully trained on the proper method to reconstitute the directcheck pt abnormal control vial. Protective sheath provide as a safeguard against possible injury was not utilized by the end user. Itc has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2015-00002 |
| MDR Report Key | 4620276 |
| Report Source | 05,06 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-03-05 |
| Date Mfgr Received | 2015-03-05 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-05-18 |
| 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 | 2015-03-18 |
| Model Number | DCJCPT-A |
| Catalog Number | DCJCPT-A |
| Lot Number | F4DAC004 |
| Device Expiration Date | 2015-11-01 |
| 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 | 2015-03-18 |