BD SYRINGE 5ML SALINE FILL CHINA SP
Received Dec 31, 2025 · Event occurred Nov 26, 2025
Report 2243072-2025-01549 · MDR key 23936687
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Becton DickinsonCatalog number
303536
Lot number
5061481
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Additional Manufacturer Narrative
D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE BD SYRINGE 5ML SALINE FILL CHINA SP HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE PREPARED TO LOCK THE CATHETER FOR THE PATIENT. UPON OPENING THE PRE-FILLED CATHETER LOCK SOLUTION PACKAGE, SHE DISCOVERED FOREIGN MATTER INSIDE THE LOCK SOLUTION.