MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-04 for UNKNOWN 1200-90-3030 manufactured by Universal Medical Instrument Corporation.
[693]
Sheath pulled as ordered by physician at 1400. When sheath was pulled, hub of sheath came apart from the rest of the sheath. The remaining catheter was left sticking approximately 1/3" out of insertion site. Catheter retreived with much difficulty by grasping. Patient experience more blood loss than normal when pulling sheathsinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1647 |
| MDR Report Key | 1647 |
| Date Received | 1992-11-04 |
| Date of Report | 1992-10-27 |
| Date of Event | 1992-10-26 |
| Report Date | 1992-10-27 |
| Date Reported to FDA | 1992-10-27 |
| Date Reported to Mfgr | 1992-10-27 |
| Date Added to Maude | 1992-11-06 |
| 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 | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | EYT |
| Date Received | 1992-11-04 |
| Model Number | UNKNOWN |
| Catalog Number | 1200-90-3030 |
| Lot Number | 137251 |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1564 |
| Manufacturer | UNIVERSAL MEDICAL INSTRUMENT CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-11-04 |