MAUDE Adverse Event Report: UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Spontaneous: (b)(6) pharmacist at (b)(6) hospital reported that the patient was just admitted to the hospital [exact date is unknown] from the er with a suspected port infection, but he said it looked like it was not on her veletri line.Unknown exact dates of er visit.No further information, details, or dates available.Product lot number and expiration date were systematically retrieved from the dispensing system.Reported to cvs/caremark by: health professional.

• Brand Name: PORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19212100
• MDR Text Key: 341491655
• Report Number: MW5154414
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• 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: 04/23/2024

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: 04/26/2024
• Patient Sequence Number: 1
• Treatment: ADEMPAS.; NAME: OPSUMIT.STRENGTH: 10MG. MANUFACTURER: JNJ.; PUMP CADD LEGACY.; SODIUM CHLOR INJ (1000ML/BAG).; VELETRI SD\/.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female