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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/13/2023

Event Type  Injury  

Event Description

Spontaneous report from patient.Patient reported an emergency room visit and hospitalization for 3 days from (b)(6) 2023 to (b)(6) 2023 due to bloodstream infection associated with central venous catheter, and that the specialist is aware.No further information.Consent to contact the patient's hep was not asked.All known information is contained on this form.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17005366
• MDR Text Key: 316090048
• Report Number: MW5117880
• 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: 05/22/2023

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: 05/24/2023
• Patient Sequence Number: 1
• Treatment: "STELARA PFS, FORTEO DELIVERY DEVICE".
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female