SYRINGE 5ML SALINE FILL CHINA SP
Received Feb 16, 2026 · Event occurred Feb 9, 2026
Report 1911916-2026-00071 · MDR key 24349558
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306594
Lot number
5092603
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Description of Event or Problem
DURING CATHETER SEALING AND INJECTION, FLUID LEAKED FROM THE TAIL END OF THE PRE-FILLED CATHETER FLUSHING DEVICE, AND BLOOD REFLUXED INTO THE CANNULA. IMMEDIATELY REPLACE THE PRE-FILLED CATHETER FLUSHING DEVICE AND CORRECTLY PERFORM CATHETER SEALING.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.