MalfunctionNGT
SYRINGE 5ML SALINE FILL CHINA SP
Received Jun 1, 2026 · Event occurred May 15, 2026
Report 1911916-2026-00258 · MDR key 25348723
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306594
Lot number
5073467
Product problems
- Break
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.
Description of Event or Problem
IT IS REPORTED, SYRINGE 5ML SALINE FILL CHINA SP, THE INNER CORE OF THE PREFILLED SYRINGE BROKE AT THE CONNECTION POINT WITH THE CANNULA, RENDERING THE CANNULA UNUSABLE. ADDITIONAL INFORMATION: BROKEN CONNECTION PART OF THE SCREW JOINT.