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

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Iv remodulin pt - spontaneous communication -(b)(6)., from (b)(6) hospital calling for dosing information for patient.(b)(6) confirmed patient at hospital due to central line issue.Hospitalization start date unknown.No further info provided.Patient is actively on remodulin, tadalafil and opsumit.Reported to cvs/caremark by health professional.

• Brand Name: CENTRAL LINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 17248295
• MDR Text Key: 318364354
• Report Number: MW5119069
• 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: 06/27/2023

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: 06/30/2023
• Patient Sequence Number: 1
• Treatment: OPSUMIT 10 MG, MFR: JNJ; REMODULIN ; TADALAFIL 20 MG, MFR:CIPLA USA
• Patient Outcome(s): Hospitalization
• Patient Sex: Female