BD Cathena™ Safety IV Catheter 386863Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00382903868636), received between Mar 10, 2022 and May 15, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (6 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Activation Problem

  IT WAS REPORTED BY A CUSTOMER THAT THE SOLID WHITE PIECE THAT SHIELDS THE NEEDLE STAYED ATTACHED TO THE CATHETER HUB AND THEY HAD TO PUT STRONG FORCE TO REMOVE IT. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEAR MISS OF NEEDLE STICK INJURY. THE SOLID WHITE PIECE THAT SHIELDS THE NEEDLE STAYED ATTACHED TO THE CATHETER HUB AND THE NURSE HAD TO PUT STRONG FORCE TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185802 ↗
• MalfunctionFeb 25, 2026Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT WHEN YOU PULL THE CATHENA NEEDLE BACK BLOOD MAY SPLATTER. RCC RECEIVED A COMPLAINT VIA EMAIL. WHILE AT A HOSPITAL A (B)(6) EMPLOYEE HEARD A HOSPITAL EMPLOYEE EXPRESS XXX WITH CATHENA. THE HOSPITAL EMPLOYEE INDICATED THAT ¿WHEN YOU PULL THE CATHENA NEEDLE BACK BLOOD MAY SPLATTER¿. THE PROVIDED PHOTO IS ONLY INTENDED TO PORTRAY PRODUCT CODE INFORMATION. NO BATCH WAS VISIBLE AND THE PHYSICAL UNIT IS NO LONGER AVAILABLE. DATE OF EVENT: FEBRUARY 10, 2026 HOSPITAL FACILITY: XXX FACILITY CONTACT PERSON: XXX (UNKNOWN LAST NAMES) FACILITY CONTACT INFORMATION: UNKNOWN DIRECT PHONE NUMBER OR EMAIL SAMPLE STATUS: NO SAMPLE IS AVAILABLE (EITHER PHYSICAL OR PHOTOGRAPHIC) PATIENT IMPACT: NO KNOWN PATIENT IMPACT PRODUCT CODE: 386863 (CATHENA 20GA X 1.25¿) PRODUCT BATCH: UNKNOWN THAT IS ALL THE INFORMATION THAT IS AVAILABLE AND NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444427 ↗
• MalfunctionDec 24, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY MECHANISM FAILED IT WAS REPORTED BY CUSTOMER THAT WHEN UNABLE TO ATTEMPT IV INSERTION WITH THIS CATHETER. RCC RECEIVED A COMPLAINT VIA EMAIL. PLANNING ON PLACING IV CATHETER IN PATIENT; WHEN NEEDLE REMOVED FROM PACKAGE NEEDLE RETRACTED IMMEDIATELY INTO SAFETY GUARD WITHOUT PROVOCATION. UNABLE TO ATTEMPT IV INSERTION WITH THIS CATHETER. NEEDLE PLACED INTO SHARPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888902 ↗
• MalfunctionDec 19, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC NEEDLE RETRACTION FAILED IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE DID NOT RETRACT CORRECTLY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN RN IN UNIT WAS PLACING AN IV THE NEEDLE DID NOT RETRACT CORRECTLY. IMAGE BEING SENT TO SAFETY NURSE [REDACTED] LOT NUMBER 3293975 PACKAGING SEQUESTERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23852113 ↗
• MalfunctionNov 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT CATHENA 20G WAS BEING USED BUT WOULD NOT SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593526 ↗
• MalfunctionAug 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC - SAFETY SHIELD ACTIVATION FAILURE. THIS IS EVENT 1 VERBATIM: NURSE HAD A CATHENA NOT SAFETY, NO ACCIDENTAL NEEDLE INJURIES OCCURRED THANKFULLY. PICTURE AND PRODUCT INFO ARE WHAT NURSE THINKS THE AFFECTED LOT IS FROM BUT ISN'T SURE, ANOTHER NON-SAFETY ISSUE HAPPENED AS WELL AND NURSE STUCK HERSELF BUT WAS NOT DOING A PATIENT STICK AND THIS PRODUCT INFO WAS NOT KEPT OR RELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878065 ↗
• MalfunctionAug 22, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC - SAFETY SHIELD ACTIVATION FAILURE. THIS IS EVENT 2 NURSE HAD A CATHENA NOT SAFETY, NO ACCIDENTAL NEEDLE INJURIES OCCURRED THANKFULLY. PICTURE AND PRODUCT INFO ARE WHAT NURSE THINKS THE AFFECTED LOT IS FROM BUT ISN'T SURE, ANOTHER NON-SAFETY ISSUE HAPPENED AS WELL AND NURSE STUCK HERSELF BUT WAS NOT DOING A PATIENT STICK AND THIS PRODUCT INFO WAS NOT KEPT OR RELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878061 ↗
• MalfunctionJul 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT 3 IVS FROM THIS LOT AT LEAST WITH THE DEFECT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON THIS MORNING'S HOSPITAL HUDDLE IT WAS REPORTED THAT A NEW LOT, 20G, 1" EUCLID ED. LOT 4327312. 3 IVS FROM THIS LOT AT LEAST WITH THE DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413574 ↗
• MalfunctionJun 18, 2025Retraction Problem; Activation Problem; Retraction Problem; Activation Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC NEEDLE RETRACTION FAILED IT WAS REPORTED BY CUSTOMER THAT SAFETY DID NOT ENGAGE AFTER SHE THREADED IN CATHETER. VERBATIM: SAFETY DID NOT ENGAGE AFTER SHE THREADED IN CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284674 ↗
• MalfunctionJan 31, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED BY CUSTOMER THAT SOME OF OUR IV CATHENA PRODUCTS ARE HAVING ISSUES WITH THEIR SAFETY MECHANISM NOT RETRACTING. IS THIS A KNOWN ISSUE? THIS EVENT OCCURRED (B)(6)2025 WITH ONE OF OUR NURSES. I DO HAVE THE PRODUCT IN MY OFFICE IF NEEDED FOR A RETURN. IF YOU HAVE ANYMORE QUESTIONS, PLEASE LET ME KNOW. VERBATIM: PLEASE ADVISE - IT WAS REPORTED THAT SOME OF OUR IV CATHENA PRODUCTS ARE HAVING ISSUES WITH THEIR SAFETY MECHANISM NOT RETRACTING. IS THIS A KNOWN ISSUE? THIS EVENT OCCURRED (B)(6)2025 WITH ONE OF OUR NURSES. I DO HAVE THE PRODUCT IN MY OFFICE IF NEEDED FOR A RETURN. IF YOU HAVE ANYMORE QUESTIONS, PLEASE LET ME KNOW.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21284365 ↗
• MalfunctionDec 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILURE. IT WAS REPORTED BY CUSTOMER THAT SAFETY FEATURE ON CATHENA SAFETY IV CATHETER DID NOT ENGAGE, LEADING TO A NEEDLE STICK FOR THE CLINICIAN. VERBATIM#: SAFETY FEATURE ON CATHENA SAFETY IV CATHETER DID NOT ENGAGE, LEADING TO A NEEDLE STICK FOR THE CLINICIAN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21032731 ↗
• MalfunctionSep 9, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THEY HAVE ANOTHER FAILED SHARP GUARD. IT WAS TOLD THAT THE BLUE PIECE SEPARATES AND THE GUARD STAYS IN THE PLASTIC HOUSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I HAVE ANOTHER FAILED SHARP GUARD. I WAS TOLD THAT THE BLUE PIECE SEPARATES AND THE GUARD STAYS IN THE PLASTIC HOUSING. LOT 4116856. I HAVE THE PRODUCT. XXXXXXXXX XXXXXXXXXX MS RN NPD-BC ACNS-BC CLINICAL NURSE SPECIALIST ED/TRINITY HEALTH GRAND RAPIDS PRONOUNS: SHE/HER/HERS XXXXXXXXXXXXXXXXXXXXXX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20173975 ↗
• MalfunctionAug 30, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MATERIAL #:386863; BATCH#:4160443. IT WAS REPORTED BY CUSTOMER THAT THE SAFETY DIDNT' ACTIVATE WHEN IV WAS ADVANCED. VERBATIM: SAFETY DIDNT' ACTIVATE WHEN IV WAS ADVANCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20108847 ↗
• MalfunctionAug 30, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MATERIAL #:386863 BATCH#:4160443. IT WAS REPORTED BY CUSTOMER THAT THE CATHENA SAFETY DIDN'T ACTIVATE. VERBATIM: 18G 1.25" CATHENA SAFETY DIDN'T ACTIVATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20108734 ↗
• MalfunctionAug 23, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED BY THE CUSTOMER THAT SAFETY STUCK IN HOUSING DIDN'T ACTIVATE WHEN ADVANCING THE CATHETER. VERBATIM: SAFETY STUCK IN HOUSING, DIDN'T ACTIVATE WHEN ADVANCING THE CATHETER. 5TH TIME THIS HAS HAPPENED WITH CATHENA AT (B)(6), OTHERS HAVE BEEN REPORTED VIA PIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052503 ↗
• MalfunctionAug 22, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILURE . IT WAS REPORTED BY THE CUSTOMER THAT SAFETY MECHANISM DIDN'T ACTIVATE. VERBATIM: SAFETY MECHANISM DIDN'T ACTIVATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041912 ↗
• MalfunctionAug 13, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  MATERIAL # 386863; BATCH # 4082702. IT WAS REPORTED BY CUSTOMER THAT WHITE SAFETY MECHANISM STUCK IN HOUSING, DIDN'T COVER NEEDLE TIP WHEN CATHETER ADVANCED. VERBATIM: WHITE SAFETY MECHANISM STUCK IN HOUSING...DIDN'T COVER NEEDLE TIP WHEN CATHETER ADVANCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973639 ↗
• MalfunctionMar 12, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC NEEDLE RETRACTION FAILED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT WE HAD A 20G IV MALFUNCTION EARLIER. WHEN THE NURSE WENT TO PULL BACK THE SAFETY THE NEEDLE WOULDN¿T RETRACT. IT APPEARS TO BE BENT AND THE PATIENT HAD TO BE STUCK AGAIN BECAUSE OF IT. I HAVE ATTACHED PICTURES AND SAVED THE ANGIO THIS TIME! I HAVE IT IN MY OFFICE. VERBATIM: WE HAD A 20G IV MALFUNCTION EARLIER. WHEN THE NURSE WENT TO PULL BACK THE SAFETY THE NEEDLE WOULDN¿T RETRACT. IT APPEARS TO BE BENT AND THE PATIENT HAD TO BE STUCK AGAIN BECAUSE OF IT. I HAVE ATTACHED PICTURES AND SAVED THE ANGIO THIS TIME! I HAVE IT IN MY OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888729 ↗
• MalfunctionDec 29, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT ATTEMPTED TO PLACE PIV ON PATIENT. HAD DIFFICULTY ADVANCING NEEDLE. ONCE NEEDLE WAS ADVANCED NEEDLE PROTECTOR DID NOT ENGAGE AND NEEDLE WAS EXPOSED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DESCRIBE THE EVENT OR PROBLEM: ATTEMPTED TO PLACE PIV ON PATIENT. HAD DIFFICULTY ADVANCING NEEDLE. ONCE NEEDLE WAS ADVANCED NEEDLE PROTECTOR DID NOT ENGAGE AND NEEDLE WAS EXPOSED. NAME: BD CATHENA SAFETY IV CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 18422017 ↗
• MalfunctionJul 10, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING INSERTION WITH BD CATHENA- SAFETY IV CATHETER, BD MULTIGUARD TECHNOLOGY IT WAS DIFFICULT TO ADVANCE AND WAS DISCOVERED THAT THE NEEDLE HAD PUNCTURED THE CATHETER. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WHILE INSERTING A #20 PERIPHERAL IV, RN HAD DIFFICULTY ADVANCING THE CATHETER OVER THE NEEDLE. WHEN SHE REMOVED, IT APPEARS THAT THE NEEDLE PUNCTURED THE CATHETER. PRODUCT IS BD CATHENA- SAFETY IV CATHETER, BD MULTIGUARD TECHNOLOGY. LOT NUMBER IS 2215681.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295237 ↗
• MalfunctionMar 30, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY NOT ENGAGING ON NEEDLES. WHITE SAFETY MECHANISM IS STUCK IN CLEAR HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653047 ↗
• MalfunctionSep 12, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD CATHENA¿ SAFETY IV CATHETER WHILE INTRODUCING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE IV WAS STARTED IN THE PREOPERATIVE AREA, THE STYLETTE AND CATHETER SEPARATED INAPPROPRIATELY. ANECDOTALLY, THE ANESTHESIA ASSISTANT THAT WITNESSED THE EVENT REPORTED THAT SHE HAS SEEN THIS BEFORE - YET IT WAS UNREPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407236 ↗
• MalfunctionMay 19, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT WHILE USING BD CATHENA¿ SAFETY IV CATHETER NEEDLE WOULD NOT SEPARATE FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS SUPERVISING A STUDENT PLACING AN A 20 G IV. BEFORE WE STARTED, I EDUCATED HER ON MAKING SURE TO LOOSEN THE TOP OF THE CATHETER FROM THE BOTTOM TO MAKE SURE THEY SEPARATED OK. I WATCHED HER PERFORM THIS STEP BEFORE SHE BEGAN. SHE PLACED THE IV AND GOT BLOOD RETURN. WHEN SHE ATTEMPTED TO SEPARATE THE NEEDLE FROM THE HUB, THEY WOULD NOT SEPARATE. BLOOD ALSO FLASHED AND POOLED IN THE BACK OF THE IV PAST THE FRONT SPRING. I ASSISTED HER AND ATTEMPTED TO REMOVE IT AND WHEN IT FINALLY SEPARATED, THE NEEDLE CAME BACK WITHOUT THE SAFETY ON. LUCKILY I WAS NOT STUCK BY THE NEEDLE, BUT IT WAS A CLOSE CALL!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437066 ↗
• MalfunctionMay 19, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT 2 UNSPECIFIED BD CATHENA¿ IV CATHETERS' SAFETY SHIELD MECHANISMS FAILED TO ACTIVATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 2 CATHENA IV CATHETERS IN MY OFFICE FROM ER THAT THE SAFETY FEATURE DIDN¿T DEPLOY. WHEN THEY PULLED THE NEEDLE OUT, THE HUB DIDN¿T SLIDE INTO PLACE OVER THE END OF THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436510 ↗
• MalfunctionMar 17, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT WHILE USING A BD CATHENA¿ SAFETY IV CATHETER, THE SAFETY MECHANISM FAILED TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED SAFETY SHIELD ACTIVATION FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13800745 ↗