BURRON M3708K UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-13 for BURRON M3708K UNKNOWN manufactured by Burron Medical Inc.,.

Event Text Entries

[4022] Venupuncture by physician into left internal jugular vessel for placement of triple lumen cental venous line. Guidewire advanced without any resistance until 30cm. At that point, the wire was advanced with slight resistance then after 40cm it felt as if the wire was curling. Then, pulsating blood gushed around the wire. The wire was withdrqwn but could not be completely removed. Direct pressure was applied. Guide wire was left in and surgery physician was contacted. Patient was taken emergently to or for removal of wire. In or, it was discovered there was injury to the left common carotid. 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: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7572
• MDR Report Key: 7572
• Date Received: 1994-01-13
• Date of Event: 1993-10-06
• Date Facility Aware: 1993-10-06
• Date Reported to Mfgr: 1993-10-19
• Date Added to Maude: 1994-05-02
• 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
• Generic Name: TRIPLE LUMEN CATHETER KIT
• Product Code: GBP
• Date Received: 1994-01-13
• Model Number: M3708K
• Catalog Number: UNKNOWN
• Lot Number: 625580
• ID Number: 331580
• Device Expiration Date: 1996-04-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7251
• Manufacturer: BURRON MEDICAL INC.,

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-01-13