BD SYRINGE 10ML SALINE FILL CHINA SP
Received Jan 20, 2026 · Event occurred Dec 16, 2025
Report 1911916-2026-00023 · MDR key 24125277
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306595
Lot number
4228701
Product problems
- Break
- 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.
Additional Manufacturer Narrative
H3: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CHINA SP BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON SEALING THE CATHETER AFTER COMPLETING THE PATIENT'S INTRAVENOUS INFUSION, A CRACK AND LEAKAGE WERE DISCOVERED IN THE BD 10ML STANDARD CORE ROD.