MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-02 for BROVIAC N/A 60064 manufactured by Davol Evermed Inc..
[4905]
When surgeon was removing the central line catheter, the catheter at the level of the cuff. This necessitated administering local anesthetic, probing for the catheter end, & using three sutures to close the wound. Device labeled for single use. Patient medical status prior to event: fair 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: device failure directly caused event, device discarded - unable to follow-up. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7502 |
| MDR Report Key | 7502 |
| Date Received | 1994-03-02 |
| Date of Report | 1993-01-27 |
| Date of Event | 1993-01-14 |
| Date Facility Aware | 1993-01-24 |
| Report Date | 1993-01-27 |
| Date Reported to Mfgr | 1993-01-27 |
| Date Added to Maude | 1994-04-26 |
| 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 | BROVIAC |
| Generic Name | 2.7 FRENCH SINGLE LUMEN VASCULAR ACCESS CATHETER |
| Product Code | FEF |
| Date Received | 1994-03-02 |
| Model Number | N/A |
| Catalog Number | 60064 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7181 |
| Manufacturer | DAVOL EVERMED INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-03-02 |