MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for PORTEX? EPIFUSE? EPIDURAL CATHETER CONNECTOR EPX1095/118JP manufactured by Smiths Medical Asd, Inc..
[108162824]
No product was returned so the reported complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[108162825]
It was reported that the customer used the epifuse connector with the combination with the hakko's filter. During use the leakage occurred from the connection of the both components.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-10048 |
| MDR Report Key | 7508288 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2015-08-11 |
| Date Added to Maude | 2018-05-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL JAPAN LTD., |
| Manufacturer Street | 627-1 YOKOUCHI KOMAKI-SHI |
| Manufacturer City | AICHI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX? EPIFUSE? EPIDURAL CATHETER CONNECTOR |
| Generic Name | CONNECTOR, CATHETER |
| Product Code | GCD |
| Date Received | 2018-05-11 |
| Catalog Number | EPX1095/118JP |
| Lot Number | 99999 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-11 |