FDA Adverse Event
Malfunction
Summary report: N
MEDEX 3-WAY STOPCOCK
MDR report key: 24927266
·
Received April 20, 2026
Report
- Report Number
- 1526863-2026-00097
- Event Type
- Malfunction
- Date Received
- April 20, 2026
- Date of Event
- March 1, 2026
- Report Date
- May 12, 2026
- Manufacturer
- ICU MEDICAL, INC.
- Product Code
- FMG
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED 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 THERE WAS A DISCREPANCY BETWEEN THE LOT NUMBER ON THE INNER LABEL (6160247) AND THE OUTER BOX LABEL (6190247). THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229662 | MEDEX 3-WAY STOPCOCK | STOPCOCK I.V. SET | FMG | ICU MEDICAL, INC. | 6190247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |