MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-29 for CONTINUOUS EPIDURAL UNKNOWN manufactured by Abbott Laboratories.
[16757963]
Upon removal of epidural catheter by the anesthesiologist, the black tip of the catheter was noted to be missing. The retained portion was noted on x-ray. The patient has chosen not tohave the retained portion removed at this timeinvalid 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3602 |
| MDR Report Key | 3602 |
| Date Received | 1992-12-29 |
| Date of Event | 1992-08-03 |
| Date Facility Aware | 1992-08-03 |
| Date Reported to Mfgr | 1992-08-19 |
| Date Added to Maude | 1993-04-26 |
| 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 | CONTINUOUS EPIDURAL |
| Generic Name | EPIDURAL CATHETER WITH STYLET INSERTION TRAY |
| Product Code | LHG |
| Date Received | 1992-12-29 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | CATH:50-3258-R-2-4189 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 3341 |
| Manufacturer | ABBOTT LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-12-29 |