MAHURKAR CATHETER KIT DULA 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 1993-06-11 for MAHURKAR CATHETER KIT DULA LUMEN CATHETER manufactured by Quinton Instrument Company.

Event Text Entries

[20196918] Residnet physician stated he felt resistance when pulling guidewire out after insertion of quinton catheter. Guidewire broke when retreived - x-ray showed 8 cm piece of wire in patient's right subclavian vein. Patient transferred to another facility for removal of wire with satisfactory results and no adverse effects at this time. Transfer due topossible need for transfusion of blood, which patient refused to consent to for religious reasons. Catheter and piece of wire which had been retreived have been retained for investigation. Manufacturer has been notifiedinvalid data - regarding single use labeling of device. 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: invalid data. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5061
• MDR Report Key: 5061
• Date Received: 1993-06-11
• Date of Report: 1993-04-19
• Date of Event: 1993-04-10
• Date Facility Aware: 1993-04-10
• Report Date: 1993-04-19
• Date Reported to Mfgr: 1993-04-19
• Date Added to Maude: 1993-06-24
• 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: MAHURKAR CATHETER KIT
• Generic Name: QUINTON CATHETER
• Product Code: FGH
• Date Received: 1993-06-11
• Model Number: DULA LUMEN CATHETER
• Lot Number: 060360
• ID Number: PART # 137 93-009
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-92
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4764
• Manufacturer: QUINTON INSTRUMENT COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-06-11