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 |