MAUDE Adverse Event Report: UNKNOWN I.V. LINE; SET, I.V. FLUID TRANSFER

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Patient believes she may have a line infection and is currently at (b)(6) medical center.Date of admittance/ discharge or current length of hospitalization is unknown.Unknown if md aware.No further info/details or dates available.Iv remodulin patient.Reported to (b)(6) by: patient/caregiver.

• Brand Name: I.V. LINE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18941548
• MDR Text Key: 338261884
• Report Number: MW5153011
• Device Sequence Number: 1
• Product Code: LHI
• 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: 03/17/2024

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: 03/19/2024
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN.; REMODULIN MDV.; SILDENAFIL CITRATE.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female