MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-26 for PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACK 100/491/716 manufactured by Smiths Medical Asd, Inc..
[128318781]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[128318782]
Information was received that a smiths medical portex csecure spinal and epidural needle assemblies - minipack cse filter leaked. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-08495 |
| MDR Report Key | 8103122 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-26 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2018-11-26 |
| 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 | 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 NORTH AMERICA |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACK |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2018-11-26 |
| Catalog Number | 100/491/716 |
| Lot Number | 3440218 |
| 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 | 2018-11-26 |