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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-27 for * manufactured by *.

Event Text Entries

[15772058] Infant had a right double lumen femoral line placed. X-ray confirmed central placement. Two days after placement, distal port had tpn running through it. Proximal port was unable to draw back blood (which it had previously). At line change, tpn was changed to the proximal port and distal port was flushing/drawing back blood. One hour later when line was checked, dressing was saturated with tpn and bed was saturated with tpn. Immediately, sterile dressing was taken down. Distal port flushed without incident. When flushing proximal port, it was noted to be leaking at the insertion site at the skin. Four days after initial line placement, it was re-wired and the femoral line was replaced. Proximal port did have a clot in the line.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2800993
• MDR Report Key: 2800993
• Date Received: 2012-09-27
• Date of Report: 2012-09-27
• Date of Event: 2011-10-16
• Report Date: 2012-09-27
• Date Reported to FDA: 2012-09-27
• Date Added to Maude: 2012-10-23
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• 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: *
• Generic Name: CATHETER, FEMORAL
• Product Code: LFK
• Date Received: 2012-09-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-27