BROVIAK 2.7 FRENCH SINGLE LUMEN CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-11 for BROVIAK 2.7 FRENCH SINGLE LUMEN CATHETER manufactured by Bard Access.

Event Text Entries

[4353] The cvc line disconnected at y-site. The patient had to return to surgery for replacement of the cvc line. The first line was placed on february 19 and the second line was placed on february 25, 1993. The patient was readmitted in april, 1993. At that time the second was noted to be doing the same thing the first line did. The line was bubbling up causing the cvc line to clot off. During this may inpatient visit, the staff thought that the line might be defective. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data, invalid data. Results of evaluation: manufacturing, invalid data. Conclusion: device failure directly caused event. 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

MAUDE Entry Details

• Report Number: 8981
• MDR Report Key: 8981
• Date Received: 1993-08-11
• Date of Report: 1993-06-25
• Date of Event: 1993-02-25
• Date Facility Aware: 1993-02-25
• Report Date: 1993-06-25
• Date Reported to FDA: 1993-06-25
• Date Added to Maude: 1994-11-04
• 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

Device Details

• Brand Name: BROVIAK 2.7 FRENCH SINGLE LUMEN CATHETER
• Product Code: FEF
• Date Received: 1993-08-11
• Lot Number: 36IC0676
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8641
• Manufacturer: BARD ACCESS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-11