MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-10-22 for DOME SUBCUTANEOUS PORT W/ GROSHONG CATHETER manufactured by Bard.
[1206]
Device was being replaced as did not function properly. Material extravisated when injected through catheter. When pulled on catheter to remove a peice broke off. This piece required further medical treatment to remove. 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 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: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1739 |
| MDR Report Key | 1739 |
| Date Received | 1992-10-22 |
| Date of Event | 1992-10-15 |
| Date Facility Aware | 1992-10-15 |
| Date Reported to Mfgr | 1992-10-15 |
| Date Added to Maude | 1992-11-19 |
| 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 | DOME SUBCUTANEOUS PORT W/ GROSHONG CATHETER |
| Product Code | LKG |
| Date Received | 1992-10-22 |
| Lot Number | 36 FA 5529 |
| ID Number | 60285 (REORDER NUMBER) |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 1645 |
| Manufacturer | BARD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-10-22 |