SYRINGE 5ML SALINE FILL CHINA SP
Received Mar 11, 2026 · Event occurred Mar 2, 2026
Report 1911916-2026-00113 · MDR key 24567920
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
303536
Lot number
5136438
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PLUNGER OF THE PRE-FILLED SYRINGE DETACHED WHILE DRAWING BLOOD. A NEW PRE-FILLED CATHETER FLUSHING DEVICE WAS REPLACED.
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.
Additional Manufacturer Narrative
THERE ARE NO SAMPLES RETURNED, SO THE INVESTIGATION OF THE SAMPLES CANNOT BE CARRIED OUT, AND IT IS IMPOSSIBLE TO DETERMINE WHETHER THE DEFECT OCCURRED DURING THE MANUFACTURING PROCESS. THEREFORE, NO RELEVANT ACTIONS WERE TAKEN.
Description of Event or Problem
NO ADDITIONAL INFORMAITON PROVIDED.