inforMED
MalfunctionNGT

BD SALINE FLUSH

Received Jun 10, 2026 · Event occurred May 28, 2026

Report 3002682307-2026-00079 · MDR key 25457963

Device

Generic name

Saline, Vascular Access Flush

Catalog number

306575

Lot number

5316477

Product problems

  • Separation Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WHITE CAP HAS COME LOOSE FROM SOME OF THE BD POSIFLUSH SP SALINE SYRINGES (10 ML, 0.9% NACL). THE LIQUID LIKELY LEAKED OUT DURING THE PRODUCTION PROCESS, AS NOTHING WAS WET WHEN THE BOXES WERE OPENED. BEFORE USE: ADDITIONAL INFORMATION PROVIDED: WHITE CAP NOT ON SYRINGE AND NO SALINE SOLUTION IN THE SYRINGE. PLASTIC FILM OF SYRINGE TORN/TORN INSIDE THE OUTER PACKAGE (CARTON). IN TOTAL, WE HAVE SORTED OUT 5 SYRINGES TO DATE.

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.