SYRINGE 10ML SALINE FILL CE
Received Jul 1, 2026 · Event occurred Jun 17, 2026
Report 3002682307-2026-00107 · MDR key 25677990
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Becton Dickinson, S.a.Catalog number
306575
Lot number
6105821
Product problems
- Material Discolored
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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
IT WAS REPORTED, SYRINGE 10ML SALINE FILL CE, CLOUDY SOLUTION. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: CLOUDY SOLUTION IN SYRINGES. WHEN DID THE INCIDENT OCCUR? BEFORE USE. IT WAS REPORTED THAT WRITING TO RAISE A CONCERN REGARDING A RECENT BATCH OF POSIFLUSH SYRINGES WE HAVE RECEIVED, REF: (B)(4), LOT:6105821. UNFORTUNATELY, ALL SYRINGES WITHIN THESE BOXES APPEAR TO CONTAIN A CLOUDY SOLUTION. THE INSTRUCTION LEAFLET INCLUDED WITH THE PRODUCT ADVISES, ¿DO NOT USE IF CLOUDY OR COLOURED,¿ WHICH HAS PROMPTED OUR CONCERN. IN OUR PREVIOUS EXPERIENCE WITH POSIFLUSH PRODUCTS, THE SOLUTION HAS ALWAYS BEEN CLEAR. AS SUCH, THIS VARIATION IS UNEXPECTED AND REQUIRES CLARIFICATION.