MalfunctionFPK
ADMINISTRATION SET
Received Jun 2, 2026 · Event occurred May 21, 2026
Report 2245270-2026-00070 · MDR key 25360606
Device
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.
Description of Event or Problem
THE LUER PULLED AWAY FROM TUBING AT THE JUNCTION OF THE TUBING AND CUFF BROKE OFF.