MAUDE Adverse Event Report: PICC LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Device Problems Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problems Arrhythmia (1721); Pain (1994)

Event Date 10/15/2021

Event Type  Injury  

Event Description

Pip/taz eclipse ball crystallized in my picc line and occluded the line.I had to go to the er to get my picc replaced.Then i had chest palpitations and severe back pain.Then my second picc line got occluded from the same medication.Fda safety report id# (b)(4).

• Brand Name: PICC LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• MDR Report Key: 12738223
• MDR Text Key: 279945933
• Report Number: MW5105080
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• 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: 10/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR