FDA Adverse Event Injury Summary report: N

CATHETER

MDR report key: 20408150 · Received October 8, 2024

Report

Report Number
MW5160865
Event Type
Injury
Date Received
October 8, 2024
Date of Event
September 16, 2024
Report Date
October 2, 2024
Manufacturer
UNKNOWN
Product Code
FOZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PHARMACIST
Health Professional
*

Narratives

Description of Event or Problem · 0

PT REPORTED LAST MONTH SHE WAS ON MAINTENANCE DOSING VELETRI SDV AND RATE OF 91ML/24H, BUT STATED HER LINE WAS CLOGGED ON (B)(6) 2024 AND HER INFUSION AT THAT TIME STOPPED FOR 2 HOURS. PATIENT REPORTED SHE WAS ADMITTED TO THE HOSPITAL AT THAT TIME AND HER INFUSION WAS STARTED BACK UP AT A LOWER UNSPECIFIED DOSE. PATIENT STATED SHE HAS A NEW LINE PLACED AND IS INFUSING FINE WITH NO ISSUES. NO FURTHER INFORMATION, DETAILS, OR DATES AVAILABLE. UNKNOWN WHEN PATIENT WAS DISCHARGED FROM HOSPITAL. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
312413 CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 47 YR Female Hospitalization OPSUMIT.| TADALAFIL.| VELETRI SDV.| WINREVAIR SDV.