MAUDE Adverse Event Report: COVIDIEN MAHURKAR QUINTON CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

The guidewire did not thread through the longer needle for the quinton kit.They were able to feed the guidewire through the shorter needle but that needle was not long enough to access the vein.The guidewire would not fit through the longer needle.Three quinton kits were opened before it was realized why the guide wire wouldn't thread through.It was 12 f and 20cm kit.This has not happened before, but it happened also the day before.The central line insertion procedure took 3 hrs and 6 central line kits before md figured it out.

• Brand Name: MAHURKAR QUINTON CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 3628340
• MDR Text Key: 4184772
• Report Number: 3628340
• Device Sequence Number: 1
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1