MAUDE Adverse Event Report: UNKNOWN IV LINE; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problems Purulent Discharge (1812); Pain (1994)

Event Date 11/02/2023

Event Type  Injury  

Event Description

Spontaneous, (b)(6) rph (registered pharmacist) at (b)(6) hospital in (b)(6), for this patient's ivt dosing.Patient being admitted for yellow drainage from her iv (intravascular) line with pain.No other information reported.Reported to (b)(6) by: health professional.

• Brand Name: IV LINE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18103838
• MDR Text Key: 327992845
• Report Number: MW5148000
• Device Sequence Number: 1
• Product Code: FPA
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: FLOLAN STERILE DILUENT (50ML).; OPSUMIT.; PUMP CADD LEGACY.; TREPROSTINIL MDV.
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female