MalfunctionNGT
SYRINGE 5ML SALINE FILL CHINA SP
Received Apr 13, 2026 · Event occurred Mar 23, 2026
Report 1911916-2026-00168 · MDR key 24858377
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
303536
Lot number
5192326
Product problems
- Crack
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.3. 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 D.3. AND G.1. DEVICE(S) MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET.
Description of Event or Problem
IT IS REPORTED, CRACK IN THE ANTERIOR PORTION OF THE FLUSH AND FLUID LEAKAGE.