MAUDE Adverse Event Report: PIC LINE

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Stroke/CVA (1770); Congestive Heart Failure (1783); Dyspnea (1816); Head Injury (1879); Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Pneumonia (2011); Hot Flashes/Flushes (2153); Pressure Sores (2326)

Event Date 02/25/2016

Event Type  Injury  

Event Description

On (b)(6) hospitalized again for congestive heart failure.Had back pain and short of breath, went to uncc er, heart infarction.Had a heart cath put on meds, diet and set to what is wellness center.I had my first foot surgery by an orthopedic surgeon in 2010 ((b)(6)) and had a nerve block and iv sedation for joint or big toe be removed due to infection, pressure ulcer was shown.Tendon in right leg cut and stitched and i had to wear a head cast for 6 weeks.I was placed on pravastatin for 14 days in (b)(6).In (b)(6) 2010, i had a stroke and a mini on (b)(6), they did a heart cath which caused me to have another stroke that affected my right side of my body.In (b)(6) 2014, i had a hot flash and passed out, cut my head, had 5 staples and had to wear a heart monitor for 14 days.Diagnosis syncope.In 2013, i had been put an iv antibiotics but i had to do myself and home health nurse.I have had pic lines 3 times and had stroke and heart attacks 6 months later.My feet had 9 surgeries, 3 on left foot for pressure ulcer and bone removed (b)(6) 2009.The first pressure ulcer surgery was in right foot (b)(6) 2007, (b)(6) 2010 - 2nd surgery, 3rd surgery in 2012, 4th in 2013, 5th in 2015, and in (b)(6) 2015 removal of 2nd toe on right foot with removal of tissue bone tendon and muscle.Five months later, 2 heart attacks, pneumonia and congestive heart failure diagnosed.Is the product compounded: yes.Is the product over-the-counter: no.How was it taken or used: iv.Dates of use: (b)(6) 2015.Whey was the person using the product: amputated toe (b)(6) 2015.Did the problem return if the person started taking or using the product again: did not start.I have had 3 pic lines put in vena cava, right arm, left arm.Pic line in right leg in (b)(6).

• Brand Name: PIC LINE
• Type of Device: PIC LINE
• MDR Report Key: 6541267
• MDR Text Key: 74476668
• Report Number: MW5069539
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CLOPIDOGREL 75 MG; FUROSEMIDE 20 MG ; JUST BABY ASPIRIN 81MG 1 DAILY; KEPRA 250 MG 1 EVERY 12 HRS; LEVETIRACETAM ; METAPROPOLE
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 63 YR
• Patient Weight: 84