5F DUAL VASCU-PICC
Received Oct 2, 2014 · Event occurred Aug 23, 2014
Report 2518902-2014-00065 · MDR key 4142707
Device
Generic name
Infusion Catheter
Manufacturer
MedcompModel number
MR17015206Catalog number
MR17015206
Lot number
MBVH580
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
87 YR
- Swelling
- Thrombosis
Narrative
Description of Event or Problem
STAFF NURSE NOTED SWELLING TO THE EXTREMITY WHERE THE PICC LINE WAS INSERTED. THE PICC LINE WAS REMOVED AND AN ULTRASOUND WAS ORDERED BY THE MD. ULTRASOUND REVEALS SEVERE OCCLUSIVE DEEP VENOUS THROMBOSIS WHICH INVOLVES THE LEFT SUBCLAVIAN, AXILLARY AND BRACHIAL VEINS.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL. A REVIEW OF THE MFG RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WITHOUT EVALUATING THE DEVICE INVOLVED IN THE COMPLAINT WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. VASCULAR THROMBOSIS AND MECHANICAL PHLEBITIS ARE KNOWN POTENTIAL COMPLICATIONS OF THIS DEVICE AND IS LISTED IN THE INSTRUCTIONS FOR USE.