BD SYRINGE 10ML SALINE FILL CHINA SP
Received Dec 17, 2025 · Event occurred Nov 28, 2025
Report 2243072-2025-01493 · MDR key 23826903
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Becton DickinsonCatalog number
303537
Lot number
5003830
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CHINA SP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTEMPTING TO FLUSH THE PATIENT'S INDWELLING NEEDLE, LEAKAGE WAS DETECTED IN THE PRE-FILLED CATHETER IRRIGATION SOLUTION.
Additional Manufacturer Narrative
D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
NO ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
BASED ON THE INVESTIGATION RESULTS AND THE ANALYSIS OF THE RETURNED PRODUCTS, THE DEFECT REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED. THE CAUSE OF THIS DEFECT IS PRESUMED TO BE LEAKAGE RESULTING FROM UNCERTAIN EXTERNAL FORCES APPLIED TO THE PRODUCT. ROOT CAUSE ANALYSIS: SYRINGE WILL BE JAMMED IN THE DIVERTER, AND THE JAM MAY CAUSE BARREL LEAKAGE. ON THE CONVEYOR LINE AT THE PACKAGING STATION, THE PRODUCT MAY BE HIGHER THAN THE CONVEYOR. AT THIS POINT, THE VACUUM CUP WILL ATTACH TO THE PRODUCT AND WILL SQUEEZE AGAINST THE PLUG ROD, CAUSING LIQUID LEAKAGE. THE HEIGHT OF THE SENSOR ON THE PACKAGING STATION CONVEYOR LINE IS TOO HIGH AND IS UNABLE TO DETECT OFFSET PRODUCTS. THE POSITION OF THE STAR WHEEL AT THE PRL FEEDING POINT DOES NOT MATCH THE ROTATION PLATE.