BURRON PERI FIX CONTNUOUS EPIDURAL ANETHESIA TRAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for BURRON PERI FIX CONTNUOUS EPIDURAL ANETHESIA TRAY manufactured by Burron - Medical Incorporated Co..

Event Text Entries

[17178599] Epidural catheter placed for pain control while patient in labor. On removal of the epidural catheter the tip was noted as missing. Spinal x-rays obtained. Unable to locate catheter tip radiologically. No special treatment rendered. Patient did not exerience any untoward affects. 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, visual examination. Results of evaluation: telemetry failure, none or unknown, unanticipated. Conclusion: device failed just prior to use, device failure directly caused event, device failure directly contributed to event, device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8748
• MDR Report Key: 8748
• Date Received: 1994-02-07
• Date of Report: 1993-11-30
• Date of Event: 1993-11-22
• Date Facility Aware: 1993-11-22
• Report Date: 1993-11-30
• Date Reported to FDA: 1993-11-30
• Date Added to Maude: 1994-10-19
• 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

Device Details

• Brand Name: BURRON PERI FIX CONTNUOUS EPIDURAL ANETHESIA TRAY
• Generic Name: EPIDURAL CATHETER
• Product Code: KNE
• Date Received: 1994-02-07
• Lot Number: 682820
• ID Number: PRODUCT CODE CE 18TB 33222
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 8409
• Manufacturer: BURRON - MEDICAL INCORPORATED CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-02-07