MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-04 for RACZ EPIDURAL CATHETER N/A 155-1353 manufactured by Medical Evaluation Devices & Instruments Corporation.
[21713647]
Caudal epidural catheter sheath broke off during pain block exposing inner wire. Neurosurgery consulted. Catheter was cut down, skin closed. Sensation and motor assessment unchangedinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: telemetry failure, unanticipated. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1310 |
| MDR Report Key | 1310 |
| Date Received | 1992-09-04 |
| Date of Report | 1992-08-24 |
| Date of Event | 1992-08-13 |
| Date Facility Aware | 1992-08-13 |
| Report Date | 1992-08-24 |
| Date Reported to FDA | 1992-08-24 |
| Date Reported to Mfgr | 1992-08-22 |
| Date Added to Maude | 1992-09-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RACZ EPIDURAL CATHETER |
| Generic Name | N/A |
| Product Code | LHG |
| Date Received | 1992-09-04 |
| Model Number | N/A |
| Catalog Number | 155-1353 |
| Lot Number | 1082R |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1254 |
| Manufacturer | MEDICAL EVALUATION DEVICES & INSTRUMENTS CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-09-04 |