TRIPLE 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 1992-07-31 for TRIPLE LUMEN CATHETER manufactured by Arrow International.

Event Text Entries

[2930] Patient had triple lumen catheter placed in the operating room prior to a surgical procedure. Chest x-ray showed no evidence of pneumothorax. Patient experienced a post-op progressive mental status change and increased slurring of speech. Arterial blood gasses drawn from triple lumen demonstrated oxygen saturation of 94%invalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4700
• MDR Report Key: 4700
• Date Received: 1992-07-31
• Date of Report: 1992-02-27
• Date of Event: 1992-02-11
• Date Facility Aware: 1992-02-11
• Report Date: 1992-02-27
• Date Added to Maude: 1993-06-02
• 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

• Generic Name: TRIPLE LUMEN CATHETER
• Product Code: GBP
• Date Received: 1992-07-31
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4416
• Manufacturer: ARROW INTERNATIONAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-31