MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-01-10 for PORTEX? SPINAL EPIDURAL MINIPACKS 100/382/116CZ manufactured by Smiths Medical Asd, Inc..
[132800228]
Information was received that a smiths medical portex epidural catheter had ruptured while being used for postoperative analgesia. The neurosurgeon performed treatment without epidural visualization. No procedure required to remove the epidural catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-00142 |
| MDR Report Key | 8236443 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-05 |
| Date Mfgr Received | 2018-12-11 |
| Date Added to Maude | 2019-01-10 |
| 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 Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL CZECH REPUBLIC A.S. |
| Manufacturer Street | OLOMOUCK |
| Manufacturer City | HRANICE, MESTO 753 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 753 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? SPINAL EPIDURAL MINIPACKS |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2019-01-10 |
| Catalog Number | 100/382/116CZ |
| Lot Number | 3049693 |
| 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 | 2019-01-10 |