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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Spontaneous communication from (b)(6)., hospital rph, (b)(6) stated pt was admitted to the hospital for potential central line infection, hospital might insert a new iv line.Pt admitted to hospital on (b)(6) 2023 and is still in the hospital.No further info/details, or dates available.Product lot number and expiration date were systematically retrieved from the dispensing system.Reported to (b)(6) by: health professional.

• Brand Name: CENTRAL LINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17463729
• MDR Text Key: 320563423
• Report Number: MW5120615
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• 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.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female