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

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Spontaneous report from iv remodulin patient.Patient is currently in the hospital for a central line issue and forgot her dosing sheet and needed to confirm dosing.Per patient there may be a blockage in her line and she reported seeing blood backflow.Unknown dates.No other information provided.Patient actively on remodulin/opsumit/tadalafil.Reported to (b)(6) by pt/caregiver.

• Brand Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 16930208
• MDR Text Key: 315292284
• Report Number: MW5117523
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 05/09/2023

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: 05/12/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN; OPSUMIT; TADALAFIL
• Patient Outcome(s): Hospitalization
• Patient Sex: Female