BD SYRINGE 5ML SALINE FILL CHINA S
Received Dec 15, 2025 · Event occurred Nov 24, 2025
Report 1911916-2025-00802 · MDR key 23810454
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306594
Lot number
5073468
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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: ON (B)(6) 2025, MEDICAL STAFF AT THE IV CENTER DISCOVERED A FUZZY, UNIDENTIFIED SUBSTANCE ADHERING TO THE INNER WALL OF A PRE-FILLED SYRINGE. THIS DELAYED TREATMENT FOR THE PEDIATRIC PATIENT, NECESSITATING THE USE OF ALTERNATIVE SUPPLIES TO RECONSTITUTE THE MEDICATION.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
Description of Event or Problem
NO ADDITIONAL INFORMATION.