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. |