FDA Adverse Event Injury Summary report: N

IV ADMINISTRATION LINE

MDR report key: 20408120 · Received October 8, 2024

Report

Report Number
MW5160864
Event Type
Injury
Date Received
October 8, 2024
Date of Event
September 16, 2024
Report Date
October 2, 2024
Manufacturer
UNKNOWN
Product Code
FPA
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT 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 THE HOSPITAL. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
312412 IV ADMINISTRATION LINE SET, ADMINISTRATION, INTRAVASCULAR FPA UNKNOWN

Patients

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