BD Cathena Safety IV Catheter 386804Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00382903868049), received between Jun 11, 2018 and May 19, 2025 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD CATHENA 20GX1.25IN STRAIGHT BC HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTER NOTICED SMALL SLIVER OF PLASTIC APPEAR AT TIP OF CANNULA AFTER MOVING INTRODUCER IN/OUT TO LOOSEN IT. OTHER CANNULA'S EXAMINED FROM SAME BOX AND SEVERAL EXHIBITED THE SAME ISSUES. THIS BOX HAS BEEN PUT ASIDE. NOTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047771 ↗
• MalfunctionApr 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BD CATHENA 20GX1.25IN STRAIGHT BC HAD COMP FRAGMENTS / PLASTIC JUST LETTING YOU KNOW THAT WE FOUND A POTENTIAL DEFECTIVE BATCH OF CATHENA 20G CANNULAS. ONE OF OUR DOCTORS NOTICED THAT A PIECE OF PLASTIC DETACHES OR RIPS OFF FROM THE CANNULA WHEN THE NEEDLE IS SLIGHTLY PULLED AND PUSHED BACKED INTO IT. THIS COULD POTENTIALLY HAPPEN WHILE IN THE VEIN. I HAVE ATTACHED A PHOTO OF THE AFFECTED BATCH AND A CANNULA WITH A DETACHED PIECE OF PLASTIC. FOR THE MEANTIME, WE HAVE PULLED OUT THE AFFECTED BATCH AND QUARANTINED THEM. WE ONLY HAVE A FEW CANNULAS WITH DIFFERENT BATCH NUMBERS AND OF WHAT LITTLE SAMPLE I TESTED WITH, I COULDN¿T FIND ANY ISSUES YET. I HAVE INFORMED THE AHC, ABOUT THIS AND SHE SAID SHE WILL INFORM THE OTHER WARDS AS WELL. AHC HAS TRIED CALLING BD ON THEIR CUSTOMER SERVICE AND MAIN OFFICE NUMBERS BUT HAS BEEN UNABLE TO REACH THEM AS IT IS THE WEEKEND. WE WILL TRY AND HAVE A LOOK AT MAIN STORES TO SEE IF WE HAVE STOCK OF ¿UNAFFECTED¿ BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891769 ↗
• MalfunctionJan 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BD CATHENA 18GX1.25IN STRAIGHT BC CATHETER TIP INTEGRITY THE UPPER PLASTIC PART OF THE CATHETER IS PARTIALLY SEVERED. SEVERAL PROFESSIONALS HAVE REPORTED THE INCIDENCE (SO FAR THREE 20G CATHETERS FROM THE SAME LOT AND ONE 18G CATHETER OF WHICH WE DO NOT KNOW THE LOT. THE AFFECTED CATHETERS ARE IN THE EMERGENCY ROOM (NURSE: SAIOA LABURU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158396 ↗
• MalfunctionNov 19, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20730087 ↗
• MalfunctionNov 19, 2024Leak/Splash; Leak/Splash

  LEAKAGE AT THE CONNECTION POINT BETWEEN CANNULA AND CATHETER DURING USE AFTER USE OF THE DEVICE ON THE PATIENT IT IS OBSERVED THAT THERE IS LEAKAGE AT THE JOINT OF THE CONE WITH THE CANNULA. OBSERVED DURING INFUSION. CATHETER ALLOWS BLOOD TO BE DRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727902 ↗
• MalfunctionAug 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CATHETER SEPARATION: "DEVICES CONNECTED TO THE CATHETER ARE DISCONNECTED AFTER A PERIOD OF TIME."

  Patient problems: Vasculitis

  MAUDE report 17466791 ↗
• MalfunctionAug 4, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: DEFECTIVE: "AFTER SUCCESSFUL INSERTION, IF BLOOD COLLECTION IS REQUIRED, IT IS NECESSARY TO REMOVE PART OF THE CATHETER.".

  Patient problems: Vasculitis

  MAUDE report 17466788 ↗
• MalfunctionNov 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD CATHENA¿ SAFETY IV CATHETER, THE DEVICE EXPERIENCED LEAKAGE (BLOOD) FROM THE FLASHBACK CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE USER CLINICIAN REPORTS THAT DURING THE INSERTION OF THE CATHETER (BDCATHENA MULTIGUARD 20G) THE MULTIGUARD SYSTEM DID NOT WORK CAUSING THE BLOOD TO LEAK. THE SEWED BLOOD HAS PARTIALLY DIRTIED THE OPERATOR'S HAND. THE ONLY IMPACT OCCURRED ON THE OPERATOR WHO HAD HIS HAND STAINED WITH BLOOD.

  Patient problems: Exposure to Body Fluids

  MAUDE report 12746559 ↗
• MalfunctionAug 20, 2021Break; Break

  IT WAS REPORTED TWO BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 20 GA 1.25 IN KINKED WHEN USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE WALLS OF THE CATHETER SEEM TO STICK TOGETHER ACCORDING TO ONE REPORTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346391 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER TIP WAS DEFECTIVE AND HAD A "METAL COIL" ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THE CONTEXT OF AN MRI-EXAMINATION THE PATIENT REPORTED UNUSUAL HEAT PAIN AT THE ARM EXACTLY WHERE THE CATHETER WAS PLACED. AFTER CHECKING THE CANNULA I NOTICED IT HAS A METAL COIL."

  Patient problems: Pain

  MAUDE report 12346364 ↗
• MalfunctionAug 19, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CATHENA 20GX1.25IN STRAIGHT BC WAS DEFECTIVE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMPOSSIBILITY AND/OR DIFFICULTY TO PUNCTURE VENOUS BLOOD. THE WALLS OF THE CATHETER SEEM TO STICK TOGETHER ACCORDING TO ONE REPORTER. NO PROBLEM WHEN ADMINISTERING AN INFUSION ON THESE SAME CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346020 ↗
• MalfunctionAug 2, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT 2 BD CATHENA¿ SAFETY IV CATHETERS' SAFETY MECHANISMS FAILED TO ACTIVATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR NURSES JUST STARTED AN IV ON A PATIENT AND WHEN THEY PULLED BACK, THE SAFETY MECHANISM DID NOT ACTIVATE, TOTALLY EXPOSING THE NEEDLE AND PUTTING STAFF AND PATIENT AT RISK OF NEEDLE STICK INJURY. ONE OTHER NURSE COMMENTED THAT IT HAS HAPPENED TO HER TWICE AND SHE IS AWARE THAT THIS FAILURE OF THE SAFETY MECHANISM HAS OCCURRED FOR OTHER STAFF RECENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260263 ↗
• MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT HAD TO BE REPICKED. WHEN PLACING THE VVP, THE CATHETER HAS ITS BASE DURING THE PLACEMENT. IT LOOKS DEFECTIVE. THE BLOOD LEAK WAS NOT DUE TO LEAVING THE STYLET AND ALLOWING BLOOD TO FLOW OUT, THE LEAK WAS WHEN THE CATHETER WAS WITHDRAWN FROM THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178532 ↗
• MalfunctionJun 2, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THERE WAS NO SAFETY DEVICE ON THE RETRACTED BD CATHENA¿ SAFETY IV CATHETER NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "APPARENTLY THERE WAS NO SAFETY ON THE RETRACTED NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925729 ↗
• MalfunctionMar 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHENA 20GX1.25IN STRAIGHT BC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANTI-REFLUX VALVE REPEATEDLY NON-FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408212 ↗
• MalfunctionFeb 11, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 20GX1.25IN STRAIGHT BC SAFETY MECHANISM WOULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A FAILURE TO DECOUPLE. THE CUSTOMER REPORTED AS FOLLOWS: AFTER ADVANCING THE CATHETER, THE HCP PULLED THE GRIP BUT THE WHITE COMPONENT WITHIN THE GRIP WAS NOT SEPARATED FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11312227 ↗
• MalfunctionJan 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO BD CATHENA¿ SAFETY IV CATHETERS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386804 BATCH NO: 8232430. PLASTIC LIKE SUBSTANCE HAS APPEARED ON/AT THE TIP OF THE CATHETER. FEELS LIKE AN ADHESIVE AGENT-SOFT AND SLIGHTLY STICKY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11160057 ↗
• MalfunctionOct 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA¿ SAFETY IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386804, BATCH NO: UNKNOWN. CT MANAGER SENT EMAIL EXPRESSING THEY ARE EXPERIENCING FREQUENT CONTRAST EXTRAVASATION EVENTS IN CT DEPT. FOR THE MOST PART USING 18G FOR HIGH FLOW RATE INJECTIONS, TEST IV'S PRIOR TO BEING HOOKED UP TO PUMP. SOME CT UNITS ARE ALSO USING 20G FOR ALL THEIR INJECTIONS. QUESTIONS/INQUIRIES: WHAT IS THE DATE(S) OF THE EVENT? HOW MANY AFFECTED ITEMS WERE INVOLVED? WHERE WAS THE LEAKAGE? DO YOU HAVE SAMPLES AVAILABLE THAT CAN BE SENT FOR EVALUATION, AND IF SO ARE THOSE CONTAMINATED? IF YOU ARE UNABLE TO SEND A SAMPLE, CAN A PHOTO BE PROVIDED? WHAT KIND OF MEDICATION WAS DRAWN FOR INJECTION WITH THE AFFECTED ITEMS? CUSTOMER RESPONSE THERE WERE SEVERAL DATES OF EVENTS. I WOULD SAY I GET 1 OR 2 EXTRAVASATION REPORTS PER WEEK. THEY EVENTS TYPICALLY OCCUR TOWARDS THE END OF THE INJECTIONS. NOT SURE WHAT YOU MEAN BY HOW MANY AFFECTED ITEMS WERE INVOLVED. NO, THERE IS NO LEAKAGE. THE VEIN SEEMS TO COLLAPSE AND THE REMAINING CONTRAST/SALINE BEGINS TO GO INTO THE INTERSTITIUM. COURSE OF TREATMENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10668512 ↗
• MalfunctionOct 9, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLOOD LEAKED THROUGH A HOLE IN THE BD CATHENA¿ SAFETY IV CATHETER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THERE WAS A TINY HOLE ON THE CATHETER; WHEN THE HCP PLACED THE CATHETER, BLOOD LEAKED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10656108 ↗
• MalfunctionAug 7, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA¿ SAFETY IV CATHETERS EXPERIENCED CATHETER DAMAGE/DEFORMATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY COLLEAGUES TELL ME THAT THEY ENCOUNTERED THE PROBLEM (CONCERNING THE 20 GA CATHETER ONLY) A FEW MONTHS AGO AND REALIZED THAT WHEN THE PATIENT'S VEIN BURST AFTER THE CATHETER WAS INSERTED, WHEN THEY REMOVED THE CATHETER THEY COULD SEE THIS SMALL PLASTIC CLUMP. HOWEVER, THESE INCIDENTS WERE NOT REPORTED INTERNALLY AND WE DID NOT KEEP THE DEFECTIVE SAMPLES OR RECORD THE LOT NUMBERS. A FEW MONTHS AGO, A NURSE NOTED THE PROBLEM WITH AT LEAST 2 PATIENTS WHOSE VEIN BROKE AFTER THE CATHETER WAS PLACED (BY REMOVING THE CATHETER, SHE NOTED A SMALL "HEAP" OF PLASTIC) BUT SHE DID NOT KEEP THE UNITS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379363 ↗
• MalfunctionAug 6, 2020Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD CATHENA¿ SAFETY IV CATHETERS EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE CATHETER: THE PLASTIC THAT IS SUPPOSED TO REMAIN IN THE VEIN FORMS A SMALL CLUMP OF PLASTIC JUST AT THE ENTRANCE WHEN YOU CHECK THAT THE NEEDLE SLIDES WELL INTO THE PLASTIC SHEATH BEFORE PRICKING THE PATIENT. THE DEVICE DOES NOT CONTAIN PRODUCT OR BLOOD. IT WAS NOT USED BECAUSE THE DEFECT WAS NOTICED BEFORE USE. SHE USED ANOTHER CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 10377126 ↗
• MalfunctionFeb 24, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED BD CATHENA SAFETY IV CATHETER20 GA 1.25 IN LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿CANNULA LEAKED SALINE WHEN FLUSHED. USER INSERTED CANNULA WITHOUT ANY ISSUE BUT COULDN'T ADVANCE IT COMPLETELY. SHE CONNECTED A POSIFLUSH TO AID ADVANCEMENT OF THE CANNULA ONLY (NEEDLE HAD BEEN WITHDRAWN) BUT WHEN SHE FLUSHED THE SALINE "SPURTED OUT" THROUGH "A HOLE" IN THE CANNULA JUST PROXIMAL TO THE HUB.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9746534 ↗
• MalfunctionSep 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE LEAKAGE OCCURRED WITH A BD CATHENA¿ SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE USER DESCRIBES THAT AFTER A FEW SECONDS BLOOD RUNS OUT OF THE BD CATHENA CATHETER, DESPITE THE MULTI QUAD FUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8984090 ↗
• MalfunctionSep 10, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT HAS BEEN REPORTED THAT THE BD CATHENA¿ BC STRAIGHT CATHETER HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AS ABOVE. PLASTIC BIT NOTED BY USERS BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 8982794 ↗
• MalfunctionSep 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD CATHENA¿ SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONTAMINATED CATHENA SAFETY CANNULA WAS FOUND IN AV SUPPLY. IT CONTAINS WHAT APPEARS TO BE A HAIR, WHICH HAS BEEN SEALED WITHIN THE PACKAGING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967702 ↗