BD POSIFLUSH
Received Mar 20, 2026 · Event occurred Feb 27, 2026
Report 3002682307-2026-00027 · MDR key 24653533
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Becton Dickinson, S.a.Catalog number
306546
Lot number
5288002
Product problems
- Material Discolored
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G.4. APPLICABLE 510K NUMBERS ARE K003553;K141311;K250884 H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE BD SYRINGE 10ML REG PR SALINE 10ML FILL HAD DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306546 BATCH # 5295643, 5288002. (B)(4) RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER STATES THEY FOUND SOME 10ML BD FLUSH SYRINGES THAT APPEAR CLOUDY. UNKNOWN TOTAL NUMBER OF QUANTITY. MORE THAN 1 FOR SURE. ADDITIONAL INFORMATION PROVIDED: PLEASE CLARIFY WHAT IS CLOUDY. THE SALINE SOLUTION? YES? THE SYRINGE/MOLDED PARTS? YES?