BD SYRINGE 10ML SALINE FILL CHINA SP
Received Nov 28, 2025 · Event occurred Oct 17, 2025
Report 1911916-2025-00772 · MDR key 23672019
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306595
Lot number
5070175
Product problems
- Leak/Splash
- Manufacturing, Packaging or Shipping Problem
- Leak/Splash
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.3. 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 LUER WAS CRACKED / DAMAGED /DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE MORNING OF (B)(6) 2025, WHILE FLUSHING A PICC LINE WITH A PRE-FILLED CATHETER FLUSHING DEVICE DURING INFUSION, LEAKAGE WAS DETECTED. INSPECTION REVEALED A CRACK AT THE SCREW CAP. THE PRE-FILLED CATHETER WAS IMMEDIATELY REPLACED, AND NORMAL USE RESUMED WITHOUT CAUSING HARM TO THE PATIENT.
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.