SYRINGE 5ML SALINE FILL CHINA SP
Received Jan 16, 2026 · Event occurred Dec 19, 2025
Report 1911916-2026-00012 · MDR key 24094148
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306594
Lot number
5105344
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT IS REPORTED SYRINGE BREAKAGE. VERBATIM: ON (B)(6), 2025, THE DIGESTIVE ENDOSCOPY CENTER AT SHANDONG PROVINCIAL MATERNAL AND CHILD HEALTH HOSPITAL INSERTED AN IV CATHETER FOR A PATIENT UNDERGOING GASTROINTESTINAL ENDOSCOPY. AFTER SEALING THE CATHETER, THE PRE-FILL SYRINGE WAS REMOVED AND FOUND TO BE FRACTURED, REMAINING INSIDE THE CATHETER. THIS DELAYED THE PATIENT'S TREATMENT. USE OF THIS CONSUMABLE HAS BEEN SUSPENDED, AND ALTERNATIVE CONSUMABLES ARE NOW BEING USED FOR PATIENT TREATMENT.
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.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
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.