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

Device Problems Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

Per (b)(6) on (b)(6) 2023: pt reported to pharmacy that tubing is leaking at filter site.She is administering iv remodulin correctly.Has a broviac catheter.Pt is being admitted to hospital today for increased shortness of breath.Md office notified to check broviac catheter for any issues.Hospitalization discharge date unknown.Iv remodulin patient.No further information known.Patient actively on remodulin /opsumit/tadalafil.Reported to (b)(6) by health professional.

• Brand Name: BROVIAC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• MDR Report Key: 16707341
• MDR Text Key: 313061811
• Report Number: MW5116491
• Device Sequence Number: 1
• Product Code: LJS
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: OPSUMIT 10MG, MFR: JNJ; REMODULIN ; TADALFIL 20MG, MFR: CIPLA USA.
• Patient Sex: Female