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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Iv remodulin patient - spontaneous communication, patient liaison reports: jeanette m, rt from md office "patient is currently admitted with a central line infection and likely discharging today with a picc line.He will need nursing follow up care for the picc line until a new broviac can be placed.At present i do not have a date on the pending broviac placement.Date of admission not provided.No other information at this time.Reported to (b)(6) by: health professional.

• Brand Name: CENTRAL LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17811051
• MDR Text Key: 324275765
• Report Number: MW5146123
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 09/18/2023

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: 09/22/2023
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN.; TADALAFIL.
• Patient Outcome(s): Hospitalization
• Patient Sex: Male