BD Cathena™ Safety IV Catheter 386860Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382903868605), received between Jul 7, 2022 and Feb 5, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT 24G PIVS LEAKING DURING APPOINTMENTS IN OUTPATIENT INFUSION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MULTIPLE 24G PIVS [PERIPHERAL INTRAVENOUS LINES] LEAKING DURING APPOINTMENTS IN OUTPATIENT INFUSION AT SITE WHERE PIV CONNECTS TO CATHETER EXTENSION SET. PIV DOES NOT LEAK WHEN CHECKING BLOOD RETURN BUT WHEN FLUSHING, PIV LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269187 ↗
• MalfunctionJan 21, 2026

  MULTIPLE 24G PIVS [PERIPHERAL INTRAVENOUS LINES] LEAKING DURING APPOINTMENTS IN OUTPATIENT INFUSION AT SITE WHERE PIV CONNECTS TO CATHETER EXTENSION SET. PIV DOES NOT LEAK WHEN CHECKING BLOOD RETURN BUT WHEN FLUSHING, PIV LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130209 ↗
• MalfunctionNov 25, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD US CATHENA 24GX0.75IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT CATHENA DID NOT SAFETY APPROPRIATELY, EXPOSING BEVEL TO PROVIDER AFTER INSERTING INTO PATIENT. VERBATIM: CATHENA DID NOT SAFETY APPROPRIATELY, EXPOSING BEVEL TO PROVIDER AFTER INSERTING INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646719 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN STRAIGHT BC - CRACK. TODAY, THREE PATIENTS REPORTED LEAKAGE OF MEDICATION FROM THEIR IV SITES. UPON ASSESSMENT, THE IV SITES WERE FOUND TO BE DAMP. THE IV CATHETERS WERE REMOVED, AND INSPECTION REVEALED THAT THE CONNECTOR COMPONENTS OF ALL THREE CATHETERS WERE SLIGHTLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874188 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN STRAIGHT BC - CRACK. TODAY, THREE PATIENTS REPORTED LEAKAGE OF MEDICATION FROM THEIR IV SITES. UPON ASSESSMENT, THE IV SITES WERE FOUND TO BE DAMP. THE IV CATHETERS WERE REMOVED, AND INSPECTION REVEALED THAT THE CONNECTOR COMPONENTS OF ALL THREE CATHETERS WERE SLIGHTLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874176 ↗
• MalfunctionAug 22, 2025Crack; Crack

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN STRAIGHT BC - CRACK. TODAY, THREE PATIENTS REPORTED LEAKAGE OF MEDICATION FROM THEIR IV SITES. UPON ASSESSMENT, THE IV SITES WERE FOUND TO BE DAMP. THE IV CATHETERS WERE REMOVED, AND INSPECTION REVEALED THAT THE CONNECTOR COMPONENTS OF ALL THREE CATHETERS WERE SLIGHTLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874164 ↗
• MalfunctionJul 3, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD US CATHENA 24GX0.75IN STRAIGHT BC NEEDLE RETRACTION FAILURE IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE NOT RETRACTING FROM HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CAN YOU SEND ME THE PR FOR: AWARENESS DATE: 6/11/2025. NEEDLE NOT RETRACTING FROM HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395473 ↗
• MalfunctionJun 30, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD US CATHENA 24GX0.75IN STRAIGHT BC NEEDLE RETRACTION FAILED IT WAS REPORTED BY CUSTOMER THAT NEEDLE NOT RETRACTING FROM HUB RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE CC¿D XXX AND XXX FROM XXXXXX TO REPORT THE COMPLAINTS BELOW: AWARENESS DATE: 6/16/2025, WE HAD ANOTHER XXXXX INCIDENT WHERE THE NEEDLE CAUGHT INSIDE THE CATHETER AND THE RN WAS NOT ABLE TO REMOVE IT, THEREFORE CAUSING THE PATIENT TO ENDURE ANOTHER PERIPHERAL STICK. #24 GAUGE BD CATHENA LOT#: 2309256, REF#: 386859 AWARENESS DATE: 6/11/2025, NEEDLE NOT RETRACTING FROM HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22363266 ↗
• MalfunctionFeb 6, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED UNKNOWN BD CATHETER SAFETY MECHANISM WILL NOT DISENGAGE FROM CATHETER / STUCK AT HUB. IT WAS REPORTED BY CUSTOMER THAT IV WAS STARTED ON PATIENT AND WHEN THE NEEDLE WAS RETRACTED OUT OF THE PATIENT, THE WHITE DEVICE THAT BLOCKS THE NEEDLE FROM GOING BACK IN CLAMPS THE BASE OF THE YELLOW 24G CATHETER AND DOES NOT ALLOW IT TO DETACH FROM THE NEEDLE DEVICE. IV SET WAS REMOVED FROM PATIENT AND ANOTHER IV WAS STARTED WITH SUCCESSFUL DETACHMENT. VERBATIM#: IV WAS STARTED ON PATIENT AND WHEN THE NEEDLE WAS RETRACTED OUT OF THE PATIENT, THE WHITE DEVICE THAT BLOCKS THE NEEDLE FROM GOING BACK IN CLAMPS THE BASE OF THE YELLOW 24G CATHETER AND DOES NOT ALLOW IT TO DETACH FROM THE NEEDLE DEVICE. IV SET WAS REMOVED FROM PATIENT AND ANOTHER IV WAS STARTED WITH SUCCESSFUL DETACHMENT. OF NOTE, WHEN MANAGER INQUIRED IF THIS WAS THE FIRST TIME THAT THIS HAD OCCURRED, THE STAFF ADVISED THAT IT HAS HAPPENED ON AND OFF IN THE PAST RANDOMLY. THE INCIDENT WAS NOT REPORTED AT THE TIME BY THE STAFF. I FOUND OUT IT HAD OCCURRED PREVIOUSLY AT THE TIME OF THE INCIDENT. I INQUIRED ABOUT THE BOXES WHEN IT OCCURRED AND I WAS TOLD MONTHS AGO AND WE NO LONGER HAD LOT INFO AVAILABLE SO I AM UNSURE O

  Patient problems: Insufficient Information

  MAUDE report 21325627 ↗
• MalfunctionFeb 6, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD US CATHENA 24GX0.75IN STRAIGHT BC SAFETY MECHANISM WILL NOT DISENGAGE FROM CATHETER / STUCK AT HUB. IT WAS REPORTED BY CUSTOMER THAT IV WAS STARTED ON PATIENT AND WHEN THE NEEDLE WAS RETRACTED OUT OF THE PATIENT, THE WHITE DEVICE THAT BLOCKS THE NEEDLE FROM GOING BACK IN CLAMPS THE BASE OF THE YELLOW 24G CATHETER AND DOES NOT ALLOW IT TO DETACH FROM THE NEEDLE DEVICE. IV SET WAS REMOVED FROM PATIENT AND ANOTHER IV WAS STARTED WITH SUCCESSFUL DETACHMENT. IV WAS STARTED ON PATIENT AND WHEN THE NEEDLE WAS RETRACTED OUT OF THE PATIENT, THE WHITE DEVICE THAT BLOCKS THE NEEDLE FROM GOING BACK IN CLAMPS THE BASE OF THE YELLOW 24G CATHETER AND DOES NOT ALLOW IT TO DETACH FROM THE NEEDLE DEVICE. IV SET WAS REMOVED FROM PATIENT AND ANOTHER IV WAS STARTED WITH SUCCESSFUL DETACHMENT. OF NOTE, WHEN MANAGER INQUIRED IF THIS WAS THE FIRST TIME THAT THIS HAD OCCURRED, THE STAFF ADVISED THAT IT HAS HAPPENED ON AND OFF IN THE PAST RANDOMLY. ITEM: BD CATHENA SAFETY IV CATHETER, LOT: 4204903, REF: 386860.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21325622 ↗
• MalfunctionJun 17, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD US CATHENA 24GX0.75IN STRAIGHT BC SAFETY MECHANISM WILL NOT ACTIVATE. IT WAS REPORTED BY CUSTOMER THAT THE SAFETY DID NOT CLICK, STATING THE ¿SAFETY COVER WAS NOT THERE¿, AND THAT THE IV CATHETER IS SUPPOSED TO CLICK AUTOMATICALLY TO ENGAGE THE SAFETY. THE SAFETY MECHANISM IS A PASSIVE SYSTEM, MEANING THAT WHEN THE NURSE PULLS BACK ON THE FROSTED PART AFTER INSERTING THE IV INTO A PATIENT, THE NEEDLE RETRACTS BACK INTO THAT FROSTED PART. WHEN FULLY OUT, THE WHOLE PART DISENGAGES FROM THE SPRING IN THE HUB, CREATING A LOCKED SAFETY ¿COVERING¿ FOR THE SHARP END OF THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THAT UPON REMOVING THE IV CATHETER, THE SAFETY DID NOT CLICK, STATING THE ¿SAFETY COVER WAS NOT THERE¿, AND THAT THE IV CATHETER IS SUPPOSED TO CLICK AUTOMATICALLY TO ENGAGE THE SAFETY. THE SAFETY MECHANISM IS A PASSIVE SYSTEM, MEANING THAT WHEN THE NURSE PULLS BACK ON THE FROSTED PART AFTER INSERTING THE IV INTO A PATIENT, THE NEEDLE RETRACTS BACK INTO THAT FROSTED PART. WHEN FULLY OUT, THE WHOLE PART DISENGAGES FROM THE SPRING IN THE HUB, CREATING A LOCKED SAFETY ¿COVERING¿ FOR THE SHARP END OF THE NEEDLE. MANUFACTURER RESPONSE FOR PERIPHERA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548240 ↗
• MalfunctionJun 6, 2024Leak/Splash; Leak/Splash

  MATERIAL #: 386860; BATCH#: 2274376; IT WAS REPORTED BY CUSTOMER THAT VALVE VOT OCCLUDING AS EXPECTED UPON INSERTION OF 24G CATHENA PIV COMPLAINT RECEIVED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 19476826 ↗
• MalfunctionAug 29, 2023Crack; Crack

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED CATHETER CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER USED A 24G NEEDLE IN HER L AC. WHEN RETRACTING THE NEEDLE, CUSTOMER NOTICED THE CATHETER BENT. USER PULLED BACK AND GOT BLOOD RETURN HOWEVER, THEY THEN NOTICED THERE WAS BLOOD COMING FROM THE IV SITE. USER ONCE AGAIN, PULLED THE CATHETER BACK AND THATS WHEN USER NOTICED IT WAS THE ACTUAL CATHETER THAT WAS CRACKED. WHEN FLUSHING THE LINE THE SALINE WAS GOING RIGHT THROUGH THE TUBING. IV WAS REMOVED AND A 22G NEEDLE WAS INSERTED INSTEAD. PATIENT DID NOTICE WHAT WAS HAPPENING, HOWEVER SHE STATES SHE FEELS FINE AND OFFERS NO COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646893 ↗
• MalfunctionJul 7, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHENA WAS NOT ABLE TO SAFETY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14951487 ↗