MAUDE Adverse Event Report: BARD POWER PICC SOLO2; CATHETER INTRAVASCULAR, THERAPEUTIC, LONGTERM

Model Number 1194108D

Device Problem Complete Blockage (1094)

Patient Problems Chest Pain (1776); Fatigue (1849); Fever (1858); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Chills (2191); Anxiety (2328); Numbness (2415); Sweating (2444); Electric Shock (2554)

Event Date 10/18/2017

Event Type  Injury  

Event Description

Bard power picc solo2 was inserted in my right arm using the 3cg stylet prior to my discharge from hospital.During the procedure, the right side of my chest down to my finger tips went numb.The nurse moved sheath/catheter around.Numbness disappeared.The next day i had an appointment with the infusion nurse at the infectious disease doctor office.She removed my bandage and the bard power picc solo2 valve.She replaced it with an unk one and wrapped my arm with a different form of bandaging.My picc became clogged a week or so into treatment.I was using saline and heparin with each infusion.The nurse vigorously flushed the line.I have had ongoing chest pain, electrical shocks, pain in arms and hands.Uti symptoms, nausea, anxiety sweats, pelvic pain, chronic fatigue, low grade fever, chills, on and off since having my picc.The picc was removed on (b)(6) 2017.I have been on oral antibiotics since to address recurring uti symptoms which my pcp states my urine culture test negative for.The uti symptoms began about a week before the picc was removed.The infectious disease doc and staff were made aware of my complication.They closed the door on me the day my picc was removed.My pcp has attributed my symptoms to my body still adjusting to the release of the antibiotics i was on.I have now had to start scheduling with specialists on my own that are willing to accept me as a self referral.

• Brand Name: POWER PICC SOLO2
• Type of Device: CATHETER INTRAVASCULAR, THERAPEUTIC, LONGTERM
• Manufacturer (Section D): BARD
• MDR Report Key: 7237755
• MDR Text Key: 98993768
• Report Number: MW5075016
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 1194108D
• Device Catalogue Number: (10)REBV0693
• Device Lot Number: REBV0693
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 59