POSIFLUSH XS/SF
Received Nov 11, 2025 · Event occurred Sep 27, 2025
Report 9616657-2025-00021 · MDR key 23527702
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
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.
Description of Event or Problem
¿IT WAS REPORTED EYE SWOLLEN SHUT - RIGHT EYELID GLAZED - BEGINNING SHORTNESS OF BREATH¿.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
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.