MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-20 for MEDIKIT SUPER SHEATH N/A IS0516 manufactured by Togo Medikit Co. Ltd..
[60860509]
A visual inspection of the returned sample was performed. A crack was observed on the syringe connector port of the main body of 3-way stopcock. Additionally, slight streak scratches which might be created by medical solution were found around the crack. It was also confirmed through testing with water that the leakage occured at the site of the crack. A review of the manufacturing process determined that there is no process during manufacturing where there would be contact with the syringe connector port of 3-way stopcock. The crack could therefore be caused due to contact with a medicinal agent such as a solution containing fat emulsion, an oily ingredient such as castor oil or solubilization agent such as a surfactant. A caution informing the user about the possibility of a crack on the 3 way stop cock connector when in contact with a oily substance is included in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[60860510]
On (b)(6) 2016 at the (b)(6) it was reported that there was blood leakage at the 3 way stop cock of the side arm tube on the medikit super sheath with catalog number is0516. There was no reported patient impact due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612126-2016-00002 |
| MDR Report Key | 6115917 |
| Date Received | 2016-11-20 |
| Date of Report | 2016-04-17 |
| Date of Event | 2016-03-31 |
| Date Mfgr Received | 2016-04-17 |
| Date Added to Maude | 2016-11-20 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YASHASWINI PATWARDHAN |
| Manufacturer Street | 747 N.MILWAUKEE AVE SUITE 102 |
| Manufacturer City | LIBERTYVILLE IL 60048 |
| Manufacturer Country | US |
| Manufacturer Postal | 60048 |
| Manufacturer G1 | TOGO MEDIKIT CO. LTD. |
| Manufacturer Street | 17148-6 AZA KAMEKAWA OAZA HICHIYA |
| Manufacturer City | HYUGA CITY, MIYAZAKI PREFECTURE 883-0062 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 883-0062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDIKIT SUPER SHEATH |
| Generic Name | CARDIAC CATHERTER INTRODUCER KIT |
| Product Code | OFC |
| Date Received | 2016-11-20 |
| Model Number | N/A |
| Catalog Number | IS0516 |
| Lot Number | NOT KNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOGO MEDIKIT CO. LTD. |
| Manufacturer Address | 17148-6 AZA KAMEKAWA OAZA HICHIYA HYUGA CITY, MIYAZAKI PREFECTURE 883-0062 JA 883-0062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-20 |