SYRINGE 10ML SALINE FILL CHINA SP
Received Jun 18, 2026 · Event occurred May 29, 2026
Report 1911916-2026-00340 · MDR key 25548235
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
303537
Lot number
5316858
Product problems
- Contamination /Decontamination Problem
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 WAS REPORTED, SYRINGE 10ML SALINE FILL CHINA SP, FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: BEFORE INFUSION, THE PATIENT PLANNED TO PERFORM A FLUSHING TUBE BUT FOUND AN ABNORMALITY AT THE PREFILLING CONNECTOR, A WHITE PLASTIC SUBSTANCE BLOCKING THE CONNECTOR, SO IT WAS IMMEDIATELY NOT USED.
Description of Event or Problem
NO ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
SINCE NO SAMPLE WAS AVAILABLE FOR RETURN AND NO PICTURES WERE RETAINED, THE DEFECT REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.