POSIFLUSH XS/SF
Received Nov 11, 2025 · Event occurred Sep 30, 2025
Report 9616657-2025-00020 · MDR key 23528133
Device
Generic name
Saline Vascular Access Flush
Manufacturer
Becton, Dickinson And Co.Catalog number
306572
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
IT WAS REPORTED ¿ALLERGIC REACTION ¿ CHILLS, HOT FLUSHES, SWEATING, RASH ON BOTH UPPER ARMS AND TRUNK, INCLUDING NECK, COVERING A LARGE AREA AND CAUSING ITCHING.
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.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: A DHR COULD NOT BE PERFORMED AS THERE WAS NO LOT LISTED IN THE COMPLAINT. AS THERE WAS NO PHYSICAL SAMPLE AVAILABLE, A SAMPLE ANALYSIS COULD NOT BE COMPLETED. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.
Description of Event or Problem
NO ADDITIONAL INFORMATION.