MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-20 for HICKMAN SUBCUTANEOUS PORT N/A 60221 (CHART) manufactured by Davol.
[20242191]
70 year old male with multiple myeloma last week difficulty accessing right port with no blood return & difficulty injecting. Today unable to use at all. Catheter check done, found to be fractured at subclavian vein & embolized to right ventricle. Removed percutaneously. Device labeled for single use. 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, performance tests performed, visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2834 |
| MDR Report Key | 2834 |
| Date Received | 1992-11-20 |
| Date of Report | 1992-06-18 |
| Date of Event | 1992-05-15 |
| Date Facility Aware | 1992-05-15 |
| Report Date | 1992-06-18 |
| Date Reported to Mfgr | 1992-05-21 |
| Date Added to Maude | 1993-03-31 |
| 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 | HICKMAN SUBCUTANEOUS PORT |
| Generic Name | HICKMAN TITANIUM PORT - ATTACHABLE LARGE VENOUS CATHETER |
| Product Code | IWI |
| Date Received | 1992-11-20 |
| Model Number | N/A |
| Catalog Number | 60221 (CHART) |
| Lot Number | 41B8DK29 (CHART) |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 2659 |
| Manufacturer | DAVOL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-11-20 |