UNKNOWN PREFILLED SYRINGE
Received Dec 13, 2025 · Event occurred Sep 7, 2025
Report 2243072-2025-01486 · MDR key 23797733
Device
Generic name
Saline Vascular Access Flush
Manufacturer
Becton DickinsonCatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Leak/Splash
- Leak/Splash
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
INVESTIGATION RESULTS: A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS NO MATERIAL AND BATCH/LOT NUMBER WAS PROVIDED. A DHR REVIEW CANNOT BE PERFORMED AS NO MATERIAL AND BATCH/LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE/MATERIAL/LOT NUMBER INFORMATION.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Description of Event or Problem
BD PRE-FILLED CATHETER FLUSHER LEAKAGE
Additional Manufacturer Narrative
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. IN THIS MDR, BD FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS THE MANUFACTURING SITE IS UNKNOWN.