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. |