MalfunctionNGT
SYRINGE 10ML SALINE FILL CHINA SP
Received Mar 9, 2026 · Event occurred Mar 1, 2026
Report 1911916-2026-00102 · MDR key 24545356
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
Additional Manufacturer Narrative
IN THIS MDR, BD COLUMBUS, NE HAS BEEN LISTED IN SECTIONS D.3. AND G.1. DEVICE(S) MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
THE PRODUCT WAS FOUND TO HAVE LEAKAGE WHILE STILL SEALED IN ITS PACKAGING.