BD Cathena™ Safety IV Catheter 386861Recalls & reported problems
Becton, Dickinson And Company · US CATHENA 22GX1.00IN STRAIGHT BC · Class 2
All models of BD Cathena Safety IV Catheter (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Cathena safety IV catheter is a short-term IV catheter with a needle-retraction safety feature. The 58 reports mostly describe the safety mechanism not working as intended: the needle shield failing to activate or retracting early, leaking, and puncturing or poking the person placing the IV, with a few needle-stick injuries noted. No deaths or injuries were recorded in the report data, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00382903868612), received between May 4, 2021 and Sep 17, 2026 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (11 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.
Reports received per month
Most reported problems
Device problems
- Activation Problem11
- Retraction Problem11
- Leak/Splash9
- Activation Failure8
- Material Puncture/Hole6
- Material Protrusion/Extrusion5
- Device Contamination with Chemical or Other Material3
- Fluid/Blood Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- Needle Stick/Puncture3
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Material Perforation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808565 ↗MalfunctionSep 11, 2026Retraction Problem; Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739939 ↗MalfunctionSep 3, 2026Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591126 ↗MalfunctionMay 13, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN STARTING IV¿S YESTERDAY ((B)(6) 2026) THEY ENCOUNTERED A FAILING SAFETY DEVICE WITH BOTH A 20G AND 22G CATHETER FROM THE LOTS REFERENCED ABOVE. ADDITIONALLY, AS THEY DIDN¿T HAVE OTHER LOT NUMBERS IN THEIR INVENTORY TO PULL FROM THIS MORNING ((B)(6) 2026), THEY ENCOUNTERED TWO OF THE 20G CATHETERS (SAME LOT # AS ABOVE) IN WHICH THE BLOOD BACKFLOW PREVENTER FAILED TO WORK. IN YESTERDAY¿S SAFETY DEVICE FAILURE INCIDENTS, ACCORDING TO THE ENDO TEAM, ONE OF THEIR CLINICIANS DID SUFFER A NEEDLE STICK WITH THE 20G CATHETER. IT APPEARS WE HAVE 3 BOXES (APPROX. 150 EACH TOTAL) OF THE 20G CATHETER, ALL THE SAME LOT #, AND 3 BOXES (APPROX. 150 EACH TOTAL) OF THE 22G CATHETER, AGAIN, ALL THE SAME LOT #, THAT WE ARE PULLING OFF THE FLOOR TO PREVENT FURTHER USAGE. VERBATIM: CATHENA 22GA AND 20GA DID NOT SAFETY APPROPRIATELY. ONE OF THE INCIDENTS CAUSED AN NSI HOPING YOU CAN HELP US NAVIGATE THIS PRODUCT ISSUE, REPORTING, RETURN, CREDIT, ETC. ACCORDING TO OUR XXXXTEAM, WHEN STARTING IV¿S YESTERDAY ((B)(6) APR2026) THEY ENCOUNTERED A FAILING SAFETY DEVICE WITH BOTH A 20G AND 22G CATHETER FROM THE LOTS REFERENCED ABOVE. ADDITIONALLY, AS THEY DIDN¿T HAVE OTH
Patient problems: Needle Stick/Puncture
MAUDE report 25162900 ↗MalfunctionMay 1, 2026Activation Problem
IT WAS REPORTED BY CUSTOMER THAT THE SAFETY RELEASED FROM CATHETER BEFORE SAFETY WAS ENGAGED VERBATIM: SAFETY RELEASED FROM CATHETER BEFORE SAFETY WAS ENGAGED, EXPOSING ME TO THE NEEDLE FOR THE DEMO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057241 ↗MalfunctionApr 30, 2026Activation Failure
IT WAS REPORTED BY THE CUSTOMER THAT EXPERIENCED QUITE A FEW NEEDLES SAFETY WHILE WE WERE DOING IN SERVICING. WE PROCEEDED TO OPEN AN ENTIRE BOX OF 22G CATHENA'S NON-WINGED, AND OUT OF THE 50 IN THE BOX, WE HAD 12 OF THEM NOT SAFETY. WE HAD EXPERIENCED QUITE A FEW NEEDLES SAFETY WHILE WE WERE DOING IN SERVICING. WE PROCEEDED TO OPEN AN ENTIRE BOX OF 22G CATHENA'S NON-WINGED, AND OUT OF THE 50 IN THE BOX, WE HAD 12 OF THEM NOT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045767 ↗MalfunctionApr 29, 2026Activation Failure
IT WAS REPORTED BY CUSTOMER THAT THE PASSIVE NEEDLE IS NOT ENGAGING PRIOR TO IT COMING OFF THE HUB OF THE IV. VERBATIM: CLINICAL SPECIALIST (XXX): DURING RETURN DEMONSTRATIONS FOR A CATHENA CONVERSION, THE PASSIVE NEEDLE IS NOT ENGAGING PRIOR TO IT COMING OFF THE HUB OF THE IV. THIS WOULD INCREASE THE RISK OF NEEDLE POKE INJURY TO CLINICIANS. I HAD TO REMOVE THE NEEDLE FROM THE CLINICIAN TO ELIMINATE THAT RISK DURING RETURN DEMONSTRATIONS. THIS HAPPENED A TOTAL OF 5 TIMES, DIFFERENT CLINICIANS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25032720 ↗MalfunctionFeb 3, 2026Activation Failure
IT WAS REPORTED BY THE CUSTOMER THAT IV INSERTION SUCCESSFUL, NO PLASTIC SAFETY CAP ON TIP OF NEEDLE WHEN IT WAS WITHDRAWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IV INSERTION SUCCESSFUL, NO PLASTIC SAFETY CAP ON TIP OF NEEDLE WHEN IT WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24250134 ↗MalfunctionJan 21, 2026Activation Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY HAD ACTIVATED BUT WHEN THEY WENT TO PUT THROW AWAY THE SHARP, THEY WERE POKED. A NURSE ON A DIFFERENT FLOOR PLACED AN IV AND STATED THAT THE SAFETY DID NOT ENGAGE LOT # 5081570, LOT # 5096085 ONE NURSE WAS INJURED FROM A NEEDLE STICK AFTER PLACING AN IV. THEY BELIEVED THAT THE SAFETY HAD ACTIVATED BUT WHEN THEY WENT TO PUT THROW AWAY THE SHARP, THEY WERE POKED. A NURSE ON A DIFFERENT FLOOR PLACED AN IV AND STATED THAT THE SAFETY DID NOT ENGAGE, THEY NOTICED THE ISSUE AND NO INJURY OCCURRED. I HAVE ATTACHED A VIDEO OF THE EVENT. IT ONLY REQUIRES MODERATE PRESSURE TO DISENGAGED WHILE STARTING THE IV ESPECIALLY FOR THE SMALLER GAUGES.
Patient problems: Needle Stick/Puncture
MAUDE report 24131973 ↗MalfunctionJan 21, 2026Activation Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY HAD ACTIVATED BUT WHEN THEY WENT TO PUT THROW AWAY THE SHARP, THEY WERE POKED. A NURSE ON A DIFFERENT FLOOR PLACED AN IV AND STATED THAT THE SAFETY DID NOT ENGAGE LOT # 5081570, LOT # 5096085 ONE NURSE WAS INJURED FROM A NEEDLE STICK AFTER PLACING AN IV. THEY BELIEVED THAT THE SAFETY HAD ACTIVATED BUT WHEN THEY WENT TO PUT THROW AWAY THE SHARP, THEY WERE POKED. A NURSE ON A DIFFERENT FLOOR PLACED AN IV AND STATED THAT THE SAFETY DID NOT ENGAGE, THEY NOTICED THE ISSUE AND NO INJURY OCCURRED. I HAVE ATTACHED A VIDEO OF THE EVENT. IT ONLY REQUIRES MODERATE PRESSURE TO DISENGAGED WHILE STARTING THE IV ESPECIALLY FOR THE SMALLER GAUGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131972 ↗MalfunctionJan 20, 2026
IV INSERTION SUCCESSFUL, NO PLASTIC SAFETY CAP ON TIP OF NEEDLE WHEN IT WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115393 ↗MalfunctionDec 19, 2025Activation Failure; Activation Failure
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE SAFETY COVER DID NOT RETRACT PROPERLY DURING INSERTION LEAVING ENTIRE LENGTH OF NEEDLE EXPOSED, NO INJURY TO PATIENT OR INJURY/EXPOSURE TO STAFF, NEEDLE DISPOSED OF IN SHARPS CONTAINER. RCC RECEIVED A COMPLAINT VIA EMAIL. PERIPHERAL IV CATHETER INSERTED, NEEDLE SAFETY COVER DID NOT RETRACT PROPERLY DURING INSERTION LEAVING ENTIRE LENGTH OF NEEDLE EXPOSED, NO INJURY TO PATIENT OR INJURY/EXPOSURE TO STAFF, NEEDLE DISPOSED OF IN SHARPS CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853632 ↗MalfunctionDec 19, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC NEEDLE RETRACTION FAILED IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES DID NOT SAFETY WHEN REMOVED FROM CATHETER. THEY WOULD SAFETY WITH A LITTLE SHAKE, BUT COULD BE THREADED BACK AND FORTH UNTIL SHAKEN. VERBATIM: WHILE DEMOING PRODUCT FOR CONVERSION, SEVERAL NEEDLES DID NOT SAFETY WHEN REMOVED FROM CATHETER. THEY WOULD SAFETY WITH A LITTLE SHAKE, BUT COULD BE THREADED BACK AND FORTH UNTIL SHAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850843 ↗MalfunctionDec 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT BLOOD CONTROL ISN'T WORKING AND IS BLEEDING BACK ON PATIENT AND CLINICIAN. VERBATIM: BLOOD CONTROL ISN'T WORKING AND IS BLEEDING BACK ON PATIENT AND CLINICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729127 ↗MalfunctionDec 4, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY MECH FAILED. IT WAS REPORTED BY CUSTOMER THAT CATHENA BLOOD CONTROL SPRING DIDN'T WORK. VERBATIM: CATHENA BLOOD CONTROL SPRING DIDN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719029 ↗MalfunctionDec 4, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY MECHANICAL FAILURE. IT WAS REPORTED BY CUSTOMER THAT CATHENA BLOOD CONTROL SPRING DIDN'T WORK. VERBATIM: CATHENA BLOOD CONTROL SPRING DIDN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719014 ↗MalfunctionDec 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY THE CUSTOMER THAT BLOOD CONTROL VALVE ISN'T WORKING AND IS BLEEDING BACK PAST THE HUB - LEAKING ON PATIENTS. VERBATIM: BLOOD CONTROL VALVE ISN'T WORKING AND IS BLEEDING BACK PAST THE HUB - LEAKING ON PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717154 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT CATHENA BLOOD CONTROL SPRING DIDN'T WORK. BLOOD CAME BACK BEYOND THE HUB AND WAS DRIPPING ON PATIENTS SKIN. VERBATIM: CATHENA BLOOD CONTROL SPRING DIDN'T WORK. BLOOD CAME BACK BEYOND THE HUB AND WAS DRIPPING ON PATIENTS SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707186 ↗MalfunctionSep 10, 2025Shielding Failure; Activation Problem; Shielding Failure; Activation Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC - 386861 - SAFETY SHIELD ACTIVATION FAILURE. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE AN ISSUE WITH THE SAFETY FEATURE ON THE IV NEEDLES. ALSO REPORTED OF THREE TIMES THAT THE SAFETY MECHANISM IS NOT ACTIVATING BUT INSTEAD DETACHING COMPLETELY, LEAVING AN EXPOSED NEEDLE AFTER RETRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23014502 ↗MalfunctionAug 19, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC HAD SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED BY THE CUSTOMER THAT SAFETY DID NOT ENGAGE. ADDITIONAL LUBRICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE SEE BELOW 2 COMPLAINTS FOR MFG 386861 LOT #5037663. 1 ¿ SAFETY DID NOT ENGAGE. 2 ¿ ADDITIONAL LUBRICATION. INCIDENT DATE 8/1. AWARENESS DATE 8/4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841390 ↗MalfunctionAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT SAFETY DID NOT ENGAGE. ADDITIONAL LUBRICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE SEE BELOW 2 COMPLAINTS FOR MFG 386861 LOT #5037663. 1 ¿ SAFETY DID NOT ENGAGE. 2 ¿ ADDITIONAL LUBRICATION. INCIDENT DATE 8/1. AWARENESS DATE 8/4.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841349 ↗MalfunctionAug 15, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC - NEEDLE RETRACTION FAILURE VERBATIM: I WANTED TO BRING TO YOUR ATTENTION THAT THE 5TH FLOOR NURSING ENCOUNTERED AN ISSUE WHERE THE NEEDLE DID NOT RETRACT PROPERLY. FORTUNATELY, THERE WAS NO HARM CAUSED TO THE PATIENT. I HAVE THE NEEDLE IN MY OFFICE.BD REF 386861 LOT 5037663 EXPIRES 2028-01-31.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816269 ↗MalfunctionJul 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC LEAKED IT WAS REPORTED BY THE CUSTOMER THAT IV LOT THAT WAS LEAKING BLOOD OUT OF THE CATHETER WHEN IT WAS PLACED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. HEMATOLOGY/ONCOLOGY AT (B)(6) HAD AN IV LOT THAT WAS LEAKING BLOOD OUT OF THE CATHETER WHEN IT WAS PLACED. THEY HAVE PULLED THEM FROM STOCK, PLACED A SERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509258 ↗MalfunctionJul 15, 2025Contamination; Contamination
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN STRAIGHT BC HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT EXCESSIVE LUBRICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WAS REVIEWING THE LATEST LIST OF LOTS AND I DO NOT SEE ANY COMPLAINTS AGAINST LOTS: (B)(6) NO COMPLAINTS IN SYSTEM (B)(6) ADDED (B)(6) NO COMPLAINTS IN SYSTEM (B)(6) ADDED (B)(6) NO COMPLAINTS IN SYSTEM (B)(6) ADDED (B)(6) 22 GAUGE 2IN LENGTH (B)(6) ADDED (B)(6) NO COMPLAINTS IN SYSTEM IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC HAD FOREIGN MATTER. IT WAS REPORTED BY THE CUSTOMER THAT EXCESSIVE LUBRICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I WAS REVIEWING THE LATEST LIST OF LOTS AND I DO NOT SEE ANY COMPLAINTS AGAINST LOTS: (B)(6) NO COMPLAINTS IN SYSTEM (B)(6) ADDED (B)(6) NO COMPLAINTS IN SYSTEM (B)(6) ADDED (B)(6) NO COMPLAINTS IN SYSTEM (B)(6) ADDED (B)(6) 22 GAUGE 2IN LENGTH (B)(6) ADDED (B)(6) NO COMPLAINTS IN SYSTEM. ADDITIONAL INFORMATION GOOD MORNING, I AM UNSURE HOW MANY WERE AFFECTED, THERE WERE AFFECTED, THERE WAS A PLASTIC PIECE ON THE TIP OF THE CATHETER, THIS WAS NOTED (B)(6), I DID NOT TAKE PHOTOS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507995 ↗MalfunctionJun 22, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THE ITEM THAT THE SAFETY DEVICE NOT PERFORMING RCC RECEIVED A COMPLAINT VIA EMAIL. THE CUSTOMER REPORTED THAT THE ITEM THAT THE SAFETY DEVICE NOT PERFORMING. THEY INFORMED THE VENDOR LAST
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304496 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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