SYRINGE 10ML SALINE FILL CHINA SP
Received Feb 17, 2026 · Event occurred Jan 16, 2026
Report 1911916-2026-00073 · MDR key 24364388
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
303537
Lot number
5168024
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT IS REPORTED LEAKAGE. DESCRIPTION: USED A 10ML PRE-FILLED CATHETER FLUSHING DEVICE TO SEAL THE INDWELLING NEEDLE. AFTER DEVICE USE, LEAKAGE WAS DETECTED. AT 1020, A NEW 10ML PRE-FILLED CATHETER FLUSHING DEVICE WAS USED TO FLUSH THE INDWELLING NEEDLE. FOLLOWING THIS INTERVENTION, THE INDWELLING NEEDLE LINE REMAINED PATENT. NO FURTHER HARM WAS CAUSED TO THE PATIENT.
Additional Manufacturer Narrative
H3: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. IN THIS MDR, BD COLUMBUS, NE HAS BEEN LISTED IN SECTIONS D3 AND G1 DEVICE(S) MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET.