MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-18 for PORTEX EPIDURAL CATHETER 100/382/116CZ manufactured by Smiths Medical Asd, Inc.
[184040938]
Device history review: the portex epidural catheter was not returned for investigation. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event. A root cause was not established because the device was unavailable for investigation.
Patient Sequence No: 1, Text Type: N, H10
[184040939]
It was reported that the epidural catheter ruptured in the patient. The catheter was sectioned during the epidural block procedure. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02145 |
| MDR Report Key | 9850512 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL CZECH REPUBLIC A. S. |
| Manufacturer Street | OLOMOUCKA 306 HRANICE 1 - MESTO |
| Manufacturer City | HRANICE, 75301 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 75301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX EPIDURAL CATHETER |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | CAZ |
| Date Received | 2020-03-18 |
| Catalog Number | 100/382/116CZ |
| Lot Number | 3556412 |
| Operator | HEALTH PROFESSIONAL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |