MalfunctionNGT
SYRINGE 10ML SALINE FILL CHINA SP
Received Jun 15, 2026 · Event occurred May 26, 2026
Report 1911916-2026-00304 · MDR key 25501146
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306595
Lot number
5140927
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED, BD SYRINGE 10ML SALINE FILL CHINA SP, BROKEN DURING USE. INITIAL REPORTER VERBATIM: WHILE USING A PRE-FILLED CATHETER FLUSH SYRINGE FOR A PATIENT FOLLOWING AN IV INFUSION, A VISIBLE DEFECT WAS OBSERVED ON THE PLUNGER ROD. A NEW DEVICE WAS IMMEDIATELY PROVIDED TO THE PATIENT.
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.