FDA Adverse Event
Malfunction
Summary report: N
CADD ADMINISTRATION SETS - FLOW STOP
MDR report key: 22014314
·
Received May 13, 2025
Report
- Report Number
- 3012307300-2025-05632
- Event Type
- Malfunction
- Date Received
- May 13, 2025
- Date of Event
- April 15, 2025
- Report Date
- May 13, 2025
- Manufacturer
- SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 15019517191738
- PMA / PMN Number
- "K031361 "
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE ADMINISTRATION SET IN COMBINATION WITH CADD-SOLIS VIP, ITEM NUMBER 21-2120-0105-14L, ALARMED FOR DOWNSTREAM OCCLUSION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. RELATED COMPLAINT FOR CADD-SOLIS VIP, ITEM NUMBER 21-2120-0105-14L IS DOCUMENTED ON (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 880028 | CADD ADMINISTRATION SETS - FLOW STOP | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. | 4434713 | 15019517191738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |