FDA Adverse Event
Malfunction
Summary report: N
INF SET CLEO
MDR report key: 20999922
·
Received December 20, 2024
Report
- Report Number
- MW5163833
- Event Type
- Malfunction
- Date Received
- December 20, 2024
- Report Date
- December 16, 2024
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT REPORTED TO NURSE THAT SHE HAS DIFFICULTY OPENING DEO AND ALSO DIFFICULTY ATTACHING CLEO INFUSION TUBING TO HER CLEO SQ SITE. SHE SAYS SHE THINKS SHE GOT A "BAD BATCH" OF SUPPLIES AS THE CLEO CONNECTS AT AN ANGLE TO HER SITE INSTEAD OF SMOOTHLY. LOT NUMBER AND EXPIRATION DATE NOT PROVIDED. TRACKING INFORMATION IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. NO ALARM REPORTED. THIS ISA CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2623467 | INF SET CLEO | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | OPSUMIT| REMODULIN MDV| REMUNITY CART W/FILL AID| WINREVAIR SDV |