BD Neoflon Pro Safety Safety IV Catheter 391662Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903916627), received between Mar 29, 2019 and Sep 7, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Backflow” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Backflow; Backflow

  IT WAS REPORTED THAT WHILE USING THE BD VENFLON¿ PRO SAFETY THER WAS BLOOD BACKFLOW DURING BLOOD DRAW. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: UPON INSERTION, THERE IS NO BACK FLOW WHICH MAKE THE STAFF DO LITTLE MANIPULATION WHICH CAUSES BULGING OF THE VEIN AND SO, CAUSING MULTIPLE PRICKS FOR PATIENTS. THE NEEDLE IS LONG, THE HUB IS HEAVY. IN NICU, WE ARE COLLECTING LABORATORY SAMPLES DURING FIRST IV CANNULA INSERTION TO AVOID MANY PRICKS. BUT WITH BD IT IS DIFFICULT TO COLLECT BLOOD SAMPLE. THE DISTANCE OF NEEDLE FROM THE HUB IS LONG, SO THE BLOOD BEING ACCUMULATED IN THE HUB IS MORE BEFORE ITS DROPS TO THE SPECIMEN COLLECTION BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17702708 ↗
• MalfunctionOct 18, 2022Manufacturing, Packaging or Shipping Problem; Activation Problem; Manufacturing, Packaging or Shipping Problem; Activation Problem

  IT WAS REPORTED THAT THE BD NEOFLON PRO SAFETY CATHETER EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPRING INSIDE PIVC/FLASH CHAMBER GOT STUCK AND BLOOD SAMPLES COULD NOT BE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621026 ↗
• InjurySep 14, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT NEOFLON PRO SAFETY 24GX0.75IN WINGED NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHILD BEING CANNULATED. REGISTRAR REMOVED NEEDLE FROM SAFETY CANNULA. NEEDLE WAS DIFFICULT TO REMOVE AND THE SAFETY CATCH FAILED TO DEPLOY LEAVING NEEDLE EXPOSED AND CAUSING DOCTOR TO SUSTAIN NEEDLE STICK INJURY.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 12467880 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED THAT THE BD NEOFLON PRO SAFETY IV CATHETER WITH WINGS 24 GA 0.75 IN EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR THE ADMINISTRATION OF CHEMOTHERAPY THERAPY, WE PROCEED WITH THE POSITIONING OF A PERIPHERAL VENOUS CATHETER. WE PROCEED WITH THE DETACHMENT PROCEDURE (MINIMUM RETRACTION OF THE SPINDLE AND ADVANCEMENT IN THE INITIAL POSITION) AND WITH VENIPUNCTURE. GIVEN THE PRESENCE OF BLOOD IN THE REFLUX CHAMBER, THE MANDREL WAS SIMULTANEOUSLY RETRACTED AND THE CATHETER WAS ADVANCED. DURING THIS PROCEDURE IT WAS POINTED OUT THAT THE CATHETER WAS PARTIALLY CUT ABOUT ONE CENTIMETER FROM THE TIP. THE DEVICE WAS THEN REMOVED AND PLACED AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9405288 ↗
• InjuryMar 29, 2019Backflow

  IT WAS REPORTED THAT THERE HAVE BEEN ONGOING ISSUES WITH THE BACK FLOW OF BD¿ NEOFLON PRO SAFETY 24GX0.75IN WINGED ONCE THE SAFETY DEVICE IS REMOVED. HEALTHCARE WORKER EXPOSED TO BLOOD. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 8464993 ↗