MAUDE Adverse Event Report: CENTRAL LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Pt reports they are currently in england and hospitalized due to central line infection (onset date unknown] and will have a new line placed.Date of admittance or current length of hospitalization is unknown.Unknown if md is aware.No further info, details or dates available.Iv remodulin pt.Reported to cvs/caremark by pt/caregiver.

• Brand Name: CENTRAL LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 17887390
• MDR Text Key: 325301233
• Report Number: MW5146683
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2023
• Patient Sequence Number: 1
• Treatment: CREMITRAM ER; LETAIRIS; PUMP CADD LEGACY; REMODULIN MDV; STERILE DILUENT FOR REMODULIN
• Patient Outcome(s): Hospitalization
• Patient Sex: Female