MAUDE Adverse Event Report: C.R. BARD, INC. POWERPICC SOLO; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fever (1858); Pain (1994); Chills (2191)

Event Date 08/09/2020

Event Type  Injury  

Event Description

Many episodes of debilitating bone pain, fever, rigors, etc.Many drs, lab tests, cultures, er visits over 5 months.Turned out to be two bacteria in picc line and i was flushing it into my bloodstream every day for five months.Picc removed.Too many tests to list below.Second bacteria found pantoea species.Neither of these bacteria were found in blood cultures drawn from the opposite arm over the course of five months.Only once the catheter was removed and cultured did these bacteria finally get picked up.Patient (myself) suffered debilitating "mystery illness" for five months.Fda safety report id # (b)(4).

• Brand Name: POWERPICC SOLO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 11378042
• MDR Text Key: 233817368
• Report Number: MW5099623
• Device Sequence Number: 1
• Product Code: LJS
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 73