BD Cathena Safety IV Catheter 386815Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903868155), received between Jul 14, 2020 and Aug 23, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN WINGED BC NEEDLE RETRACTION FAILED. IT WAS REPORTED BY THE CUSTOMER THAT UNKNOWN ISSUE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE SEE BELOW FOR ANGIO PICTURE FROM BARRHEAD COMPLAINT. UNKNOWN ISSUE. PRODUCT NUMBER - 386815. ADDITIONAL INFO: 1. I INSERTED IV, GOT FLASH OF BLOOD, TRIED TO ADVANCE CATHETER INTO VEIN, BUT NEEDLE WOULD NOT RETRACT. I WAS ABLE TO WIGGLE IT LOOSE, AND IT DID COME OFF THE PLASTIC CATHETER EVENTUALLY, BUT THE NEEDLE CAME OUT EXPOSED AND NOT COVERED BY THE SAFETY SHEATH. 2. NO. 3. 2 OCCURENCES THAT I AM AWARE OF. 4. NO SAMPLE AVAILABLE. I DISPOSED OF IT IN SHARPS CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057562 ↗
• MalfunctionAug 22, 2024Retraction Problem; Retraction Problem

  MATERIAL # 386815 BATCH # 3267040. IT WAS REPORTED BY CUSTOMER THAT THEY STARTED AN IV WITH 24 G NEEDLE, AND WHEN THEY WENT TO RETRACT THE NEEDLE INTO THE SAFETY SHEATH, IT WAS STUCK AND WOULD NOT RETRACT. RCC RECEIVED A COMPLAINT VIA EMAIL. AHS MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6)2024 SITE NAME/LOCATION: XXXXXX LEVEL OF HARM: NO APPARENT HARM ¿ CLOSE CALL AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES INCIDENT DETAILS: I STARTED AN IV WITH 24 G NEEDLE, AND WHEN I WENT TO RETRACT THE NEEDLE INTO THE SAFETY SHEATH, IT WAS STUCK AND WOULD NOT RETRACT. I DID MANAGE TO GET IT OUT WITH FORCEFUL WIGGLING AND PULLING, BUT THE NEEDLE WAS EXPOSED. IMPACT OF INCIDENT: THE IV WAS STILL OKAY, SO NO HARM TO THE PATIENT OTHER THAN A LITTLE DISCOMFORT FROM WIGGLING THE NEEDLE. WHO WAS AFFECTED? PATIENT DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY WINGED WITH MULTIGUARD 24GAX0.75IN CATHENA MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 386815 SERIAL OR LOT NUMBER: (B)(6) DEVICE EXPIRY DATE (YYYY-MM-DD): UNKNOWN SUPPLIER: XXXXX SUPPLIER CATALOGUE NUMBER: 333-386815 WAS THE DEVICE RETAINED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026945 ↗
• MalfunctionMay 24, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN WINGED BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT WHEN RETRACTING THE NEEDLE IT WAS STUCK TO THE CATHELON. ATTEMPTING TO REMOVE IT WITH REQUIRED EXCESSIVE FORCE, DISLODGE THE CATHETER, TWICE THIS OCCURRED BOTH WITH 24S. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): 40619 DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024 SITE NAME/LOCATION: BONNYVILLE HEALTHCARE CENTRE LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: 24 GAUGE IV BD CATHENA REF (B)(4) WHEN RETRACTING THE NEEDLE IT WAS STUCK TO THE CATHELON. ATTEMPTING TO REMOVE IT WITH REQUIRED EXCESSIVE FORCE, DISLODGE THE CATHETER, TWICE THIS OCCURED BOTH WITH 24S. IMPACT OF INCIDENT: 2 SUCCESSFUL IV INSERTIONS FAILED DUE TO CATHELON BEING DISLODGED WHEN RETRACTING THE NEEDLE DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY WINGED WITH MULTIGUARD 24GAX0.75IN CATHENA MANUFACTURER: BECTON DICKINSON CANADA INC SERIAL OR LOT NUMBER: UNKNOWN DEVICE EXPIRY DATE (YYYY-MM-DD): UNKNOWN SUPPLIER: THE STEVENS COMPANY LTD SUPPLIER CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392381 ↗
• InjuryMay 25, 2023Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED THAT 12 OF THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY NEEDLE INSERTION WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PEDIATRIC PATIENT HAD 10 IV ATTEMPTS ON THE UNIT AND 2 ATTEMPTS IN THE OR BEFORE FINALLY HAVING SUCCESS OBTAINING IV ACCESS. THE CATHLONS INVOLVED WERE CATHENA AND POWER PORT CATHLONS FOR CT. STAFF ON THIS UNIT FREQUENTLY HAVE DIFFICULTY WITH CATHENA CATHLONS, MANY CHILDREN ARE SUFFERING THE TRAUMA OF MISSED IV ACCESS ATTEMPTS. IMPACT OF INCIDENT: PATIENT TAKEN TO THE OR FOR IV ACCESS WITH SEDATION. PATIENT DISCOMFORT AND LIKELY A TRAUMATIC EVENT FOR THIS YOUNG PATIENT.

  Patient problems: Discomfort

  MAUDE report 17008232 ↗
• MalfunctionJun 3, 2022Retraction Problem; Failure to Eject; Retraction Problem; Failure to Eject

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY THE SPRING REMAINED IN THE CANNULA AFTER REMOVING THE SAFETY NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH. "A FEW WEEKS AGO I SPOKE TO YOU ABOUT A COMPLAINT WITH THE YELLOW NEOFLONS FROM BD. THE SPRING REMAINED IN THE CANNULA AFTER REMOVING THE SAFETY NEEDLE. WE THOUGHT THAT IT WAS LIMITED TO ONE PARTICULAR LOT NUMBER AT THE TIME, BUT NOW TODAY WE HAVE FOUND NEOFLONS AGAIN WITH THE SAME PROBLEM, AND A DIFFERENT LOT NUMBER. I HAVE OPENED A NUMBER OF THEM AND THEY ALL HAD THE PROBLEM. SOME OTHER LOT NUMBERS DID NOT. I HAVE TAKEN THEM OUT OF SERVICE AGAIN. THIS TIME IT WAS A LARGE PART OF OUR STOCK!" ALSO THIS TIME IT CONCERNS THE ALTERNATIVE THE CATHENA WITH REF 386815 BUT NOW WITH LOT NUMBER: 1337251.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598338 ↗
• MalfunctionMay 31, 2022Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY SAFETY SHIELD FAILED AND BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM "TODAY I RECEIVED A COMPLAINT SIMILAR TO THE ONE BELOW FROM MY COLLEAGUES IN ANAESTHESIA. THEY HAVE LOT NUMBERS 1337251 AND 9331601. PHOTOS OF THE COMPLAINT FROM ANAESTHESIA... SPEAK FOR THEMSELVES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547266 ↗
• MalfunctionMay 7, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THE SAFETY MECHANISM FAILED TO ACTIVATE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE'RE HAVING TROUBLE WITH BD'S NEOFLON IV NEEDLES. AFTER INSERTING THE NEOFLON, WITHDRAW THE NEEDLE LEAVING ONLY THE CANNULA IN THE PATIENT'S VESSEL. IN THIS CASE, THE SAFETY MECHANISM SPRING REMAINED IN THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317957 ↗
• MalfunctionApr 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD CATHENA¿ SAFETY IV CATHETERS WITH WINGS BD MULTIGUARD¿ TECHNOLOGY HAD ISSUES WITH THE NEEDLE PIERCING THROUGH THE CATHETER, RESULTING IN BLOOD LEAKAGE THROUGH THE HOLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 SEPARATE RNS EXPERIENCED SAME INCIDENT IN SAME DAY AND NEITHER HAD EXPERIENCED IT PRIOR DESPITE USING PRODUCT FOR SOME TIME- DURING IV START, NEEDLE WENT THROUGH PLASTIC CATHELON RESULTING IN BLOOD FLOW THROUGH HOLE IN CATHELON AND FAILED IV START."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638796 ↗
• MalfunctionAug 7, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHENA 24GX0.75IN WINGED BC WILL NOT MOVE FORWARD CAUSING THE PATIENT'S VEIN TO BLOW AND BLOOD TO FLOW. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 386815 BATCH NO: UNKNOWN IT WAS REPORTED THAT WHEN INTRODUCING THE ABOVE CATHLON INTO PATIENT¿S VEIN THE PLASTIC CATHLON WILL NOT MOVE FORWARD, CAUSING THE VEIN TO BLOW. ON A NUMBER OF OCCASIONS BLOOD FLOW ON INSERTION WHEN REMOVING THE NEEDLE OCCURS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382618 ↗
• MalfunctionAug 4, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY WAS DAMAGED AND STILL OPERABLE. THERE WAS ALSO BLOOD EXPOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "- THE BLOOD-CONTROL SYSTEM OF SOME DEVICES DID NOT WORK CAUSING THE EXIT OF THE BLOOD THAT HAS SMEARED THE OPERATOR EXPOSING HIM TO BIOLOGICAL RISK; - MANY TIMES THE CONNECTION WITH THE CONE CONNECTOR HAS BEEN MADE VERY DIFFICULT DUE TO THE EXCESSIVE FORCE TO BE APPLIED FOR THE SECURE CONNECTION; - IN A FEW CASES THE ACTIVATION OF THE SAFETY SYSTEM CAUSED THE TWISTING OF THE CATHETER CANNULA; - IN SOME CASES THE INSTAFLASH SYSTEM DID NOT WORK PROPERLY MAKING IT DIFFICULT TO ACCESS THE PATIENT'S VEIN".

  Patient problems: Exposure to Body Fluids

  MAUDE report 10365257 ↗
• MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH WINGS BD MULTIGUARD¿ TECHNOLOGY VALVE LEAKED BLOOD DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE NEW CATHETERS ARE EXTREMELY DIFFICULT TO USE. THEY DO NOT THREAD AFTER A BLOOD FLASH HAS BEEN SEEN. THE FAILURE RATE WITH THESE CATHETERS IS HIGH. THE VALVE OFTEN LEAKS. WHEN ATTEMPTING TO DRAW LABS (ESPECIALLY ON PEDIATRIC PATIENTS) THE VALVE PREVENTS THIS AND RESULTS IN A SECOND INVASIVE PROCEDURE ON A CHILD. THIS IS A DRAMATICALLY INFERIOR PRODUCT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10269545 ↗