MAUDE Adverse Event Report: I.V. TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Spontaneous.(b)(6) medical center reports patient is admitted for unspecified iv line issues; pump was alarming for blockage detected.Unknown if patient was admitted late last night (b)(6) 2023 or this morning (b)(6) 2023.No further information, details or dates available.Iv remodulin pt.Pt is actively taking remodulin and opsumit.Reported to cvs/caremark by health professional.

• Brand Name: I.V. TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 17086410
• MDR Text Key: 316880377
• Report Number: MW5118268
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/03/2023

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: 06/07/2023
• Patient Sequence Number: 1
• Treatment: OPSUMIT 10 MG, MFR: JNJ; PUMP; REMODULIN
• Patient Outcome(s): Hospitalization
• Patient Sex: Female