BD Cathena Safety IV Catheter 386807Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00382903868070), received between Feb 22, 2019 and Jul 30, 2025 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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.

• MalfunctionJul 30, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN STRAIGHT BC CATHETER DEFECTIVE / DAMAGED IT WAS REPORTED BY CUSTOMER THAT THERE IS A BUBBLE THAT FORMS AND ARE NOT ABLE TO PROPERLY PRICK THE PATIENT THAT HE CAN TAKE IT SEVERAL TIMES BEFORE HE SUCCEEDS IN THE INJECTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CAT# OF PRODUCT BEING COMPLAINED: BD386807 DESCRIPTION OF PRODUCT: CATHENA 24GX0.75IN STRAIGHT BC 50EA/BX 4BX/CA LOT OR S/N: (B)(6). COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO INCIDENT DATE: (B)(6) 2025. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): "THE CLINIC INFORMS ME THAT THERE IS A BUBBLE THAT FORMS AND ARE NOT ABLE TO PROPERLY PRICK THE PATIENT THAT HE CAN TAKE IT SEVERAL TIMES BEFORE HE SUCCEEDS IN THE INJECTION. WE HAVE 3 BOXES AND 45 UNITS OF THIS PRODUCT." COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 3 BX SAMPLES AVAILABLE? YES, IS CUSTOMER REQUESTING AN RGA? NO RETURN QTY: QTY SAMPLES: 3 BX CUSTOMER RESPONSE: SOME CATHETERS HAVE A BUBBLE IN THEIR PLASTIC AT THE END. THIS CAUSES A RUPTURE OF THE PATIENT¿S VEIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666201 ↗
• MalfunctionJun 11, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT BD CATHENA 24GX0.75IN STRAIGHT BC CATHETER DEFECTIVE/DAMAGED IT WAS REPORTED BY CUSTOMER THAT THE CATHLONS ARE BUBBLED AT THE TIP, THIS CAUSES AN INABILITY TO GO THROUGH THE SKIN AND IF THEY MANAGE TO GET THROUGH THE SKIN, IT GETS CAUGHT UP TRYING TO GET INTO THE VEIN. THIS ENDS UP OFTEN BEING 2 IV ATTEMPTS FOR THE PATIENT. RCC RECEIVED A COMPLAINT VIA EMAIL. AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025 TYPE OF INCIDENT/PROBLEM: FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: MINIMAL HARM AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: CATHLONS ARE "BUBBLED" AT THE TIP, THIS CAUSES AN INABILITY TO GO THROUGH THE SKIN AND IF YOU MANAGE TO GET THROUGH THE SKIN IT GETS CAUGHT UP TRYING TO GET INTO THE VEIN. THIS ENDS UP OFTEN BEING 2 IV ATTEMPTS FOR THE PT, ALL STAFF HAVE NOTICED THIS AS AN ISSUE FOR AT LEAST THE LAST 4 WEEKS. PROCEDURE: IV INSERTION DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV SAFETY NON-WINGED WITH MULTIGUARD 24GAX0.75IN CATHENA MANUFACTURER: XXXXXXXX MANUFACTURER CODE/MODEL: 386807 SERIAL OR LOT NUMBER: UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186981 ↗
• MalfunctionAug 7, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY WAS DEFECTIVE DURING USE, WITH PART OF THE CATHETER HAVING TO BE REMOVED TO COMPLETE THE BLOOD COLLECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOUR DEFECTS ARE: 1) LEAKAGE AT INSERTION SIDE: "IT IS REPORTED THAT AFTER INSERTION OF THE CATHETER THE INSERTION SITE IS VERY DILATED, WHICH EVEN CAUSES THE MEDICATION TO LEAK OUT ALMOST UNNOTICED." 2) PHLEBITIS: "INCREASED INCIDENCE OF PHLEBITIS. SINCE USING THE CATHETER, THEY HAVE NOTICED AND MEASURED AN INCREASE IN MECHANICAL PHLEBITIS THAT DEVELOPS WITHIN A FEW HOURS AFTER INSERTION OF THE DEVICE." 3) DEFECTIVE: "AFTER SUCCESSFUL INSERTION, IF BLOOD COLLECTION IS REQUIRED, IT IS NECESSARY TO REMOVE PART OF THE CATHETER." 4) CATHETER SEPARATION: "DEVICES CONNECTED TO THE CATHETER ARE DISCONNECTED AFTER A PERIOD OF TIME."

  Patient problems: Vasculitis

  MAUDE report 17472219 ↗
• MalfunctionAug 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY DISCONNECTED FROM THE HUB DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOUR DEFECTS ARE: 1) LEAKAGE AT INSERTION SIDE: "IT IS REPORTED THAT AFTER INSERTION OF THE CATHETER THE INSERTION SITE IS VERY DILATED, WHICH EVEN CAUSES THE MEDICATION TO LEAK OUT ALMOST UNNOTICED." 2) PHLEBITIS: "INCREASED INCIDENCE OF PHLEBITIS. SINCE USING THE CATHETER, THEY HAVE NOTICED AND MEASURED AN INCREASE IN MECHANICAL PHLEBITIS THAT DEVELOPS WITHIN A FEW HOURS AFTER INSERTION OF THE DEVICE." 3) DEFECTIVE: "AFTER SUCCESSFUL INSERTION, IF BLOOD COLLECTION IS REQUIRED, IT IS NECESSARY TO REMOVE PART OF THE CATHETER." 4) CATHETER SEPARATION: "DEVICES CONNECTED TO THE CATHETER ARE DISCONNECTED AFTER A PERIOD OF TIME.""

  Patient problems: Vasculitis

  MAUDE report 17472216 ↗
• MalfunctionJul 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE WITH BD CATHENA¿ SAFETY IV CATHETER THE CATHETER WAS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER ATTEMPTED TO START AN IV ON A HARD START. PATIENT NEEDED A 24GAUGE. CUSTOMER ATTEMPTED TWICE AND BOTH TIMES, GOT GREAT FLASH FILLING THE CATHALON AND THE HUB, FIRST ATTEMPT WOULD NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17276182 ↗
• MalfunctionMay 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED CATHETER SPLITTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRITER INSERTED #24 IV INTO PT'S LEFT WRIST. IV CATHETER SPLIT INSIDE PT'S VAIN UPON IV INSERTION. IV CATHETER SAFELY REMOVED FROM PT PUT VISIBLE SPLIT NOTICED WITH PLASTIC CANNULA. NEEDLE INTACT. SMALL HEMATOMA OCCURRED AT SITE OF INSERTION AFTER. WRITER HELD PRESSURE TO SITE. PT EDUCATION PROVIDED.

  Patient problems: Hematoma

  MAUDE report 16959278 ↗
• MalfunctionMar 24, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 24 GA 0.75 IN LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT LEAKAGE WITH THE CATHENA. ACCORDING TO THE CUSTOMER'S REPORT, THE LEAKAGE WAS FOUND FROM THE CONNECTION BETWEEN THE EXTENSION TUBING AND THE CATHENA HUB, WHEN THE ADMINISTRAION WAS PERFORMED WITH A CATHENA ATTACHED TO AN EXTENSION TUBING THREE TIMES DAILY IN THE MORNING, AFTERNOON, AND EVENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613025 ↗
• MalfunctionFeb 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT 1 BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY EACH FROM LOTS 2022963 AND 2110513 SPLIT APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIOMEDICAL ENGINEER RECEIVED NOTIFICATION THAT ON TWO OCCASIONS, RNS COMPLAINED ABOUT CATHENA IV CATHETER "SPLITTING""

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301572 ↗
• MalfunctionJan 25, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 24 GA 0.75 IN A CLOGGED NEEDLE WAS OBSERVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A FLOW ISSUE OF CATHENA. AFTER CATHETER PLACEMENT, BLOOD COLLECTION COULD BE COMPLETED. THE HCP CONNECTED TO AN IV SET AND STARTED THE INFUSION; HOWEVER, THE FLUID DIDN'T DRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13345575 ↗
• MalfunctionDec 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY THERE WAS LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER CATHETER PLACEMENT, THE INFUSION WAS STARTED AND LEAKAGE WAS THEN OBSERVED. WHEN THE HCP CHECKED THE PRODUCT, THE LEAKAGE WAS OCCURRING AROUND THE AREA BETWEEN THE CATHETER AND THE CATHETER HUB."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976874 ↗
• MalfunctionSep 28, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY SAFETY MECHANISM FAILED TO FULLY COVER THE NEEDLE WHEN DECOUPLED FROM THE CATHETER HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AFTER PLACING THE CATHETER INTO THE VESSEL, THE HCP COULD DECOUPLE THE SAFETY SHIELD FROM THE CATHETER HUB; HOWEVER, THE SAFETY MECHANISM DIDN'T WORK PROPERLY, AND THE NEEDLE WAS EXPOSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542288 ↗
• MalfunctionApr 29, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT BC SAFETY MECHANISM NEEDLE TIP WAS UNCOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PLACING AND ADVANCING THE CATHETER, THE HCP ACTIVATED THE SAFETY MECHANISM BUT THE NEEDLE TIP WAS UNCOVERED BY THE SAFETY SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744404 ↗
• MalfunctionFeb 16, 2021Activation, Positioning or Separation Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT BC NEEDLE WAS DIFFICULT TO DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DIFFICULT NEEDLE DISENGAGEMENT. ACCORDING TO THE CUSTOMER¿S REPORT, THE HCP ATTEMPTED TO WITHDRAW THE NEEDLE BUT FELT RESISTANCE AND COULD NOT WITHDRAW THE NEEDLE. THE HCP COMPLETED CATHETER PLACEMENT WITH ANOTHER CATHENA.

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

  MAUDE report 11336250 ↗
• MalfunctionFeb 10, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT BC SAFETY MECHANISM WOULD NOT COVER THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS OCCURRED DURING DEMONSTRATION. AFTER CATHETER PLACEMENT, THE HCP RETRACTED THE NEEDLE BUT THE WHITE COMPONENT FOR THE SAFETY MECHANISM STOPPED HALFWAY AND THE NEEDLE WAS NOT RETRACTED COMPLETELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11312002 ↗
• MalfunctionFeb 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HCP ADVANCED THE CATHETER AND ATTEMPTED TO DISENGAGE THE NEEDLE; HOWEVER, THE NEEDLE WAS NOT DISENGAGED, RESULTING IN BLOOD LEAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11298014 ↗
• MalfunctionJan 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT BC LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE HCP ADVANCED THE CATHETER AND THEN SAW BLOOD LEAKING BEFORE RETRACTING THE NEEDLE. BLOOD LEAKAGE FROM THE CATHETER HUB WAS NOT OBSERVED. THE CUSTOMER HAVE NEVER EXPERIENCED SUCH AN INCIDENT LIKE THIS BEFORE AND WOULD LIKE TO KNOW POSSIBLE ISSUES ATTRIBUTABLE TO PRODUCT DEFECT AS WELL AS TO MANIPULATIVE TECHNIQUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11168154 ↗
• MalfunctionJan 13, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT BC SAFETY MECHANISM DID NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAFETY MECHANISM DIDN'T WORK. WHEN THE CUSTOMER REMOVED THE NEEDLE, THE NEEDLE TIP SHOULD BE COVERED BY PUSH TAB. THOUGH AFTER THE NEEDLE IS PULLED OUT , NEEDLE TIP WAS NOT COVERED BY PUSH TAB AND IT WAS EXPOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11168105 ↗
• MalfunctionJan 11, 2021Leak/Splash; Material Protrusion/Extrusion; Leak/Splash; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CATHENA 24GX0.75IN STRAIGHT BC CATHETER WAS NOT SEPARATED AND THE NEEDLE WOULD NOT RETRACT COMPLETELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE CATHETER WAS NOT SEPARATED. BDJ'S SALES REP. REPORTED AS FOLLOWS: THE NEEDLE WAS NOT RETRACTED COMPLETELY. BD NEEDS TO CLOSELY INVESTIGATE IF THE CATHETER HUB IS ATTACHED TO THE SAFETY SHIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152589 ↗
• MalfunctionDec 22, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY HAD RESISTANCE WHEN BEING ADVANCED, AND WITHDRAWING IT SHOWED THE TIP HAD BEEN SPLIT AS THE NEEDLE HAD PIERCED THROUGH IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT A DAMAGED CATHETER TIP. AFTER CATHETER/NEEDLE PLACEMENT, THE HCP FELT RESISTANCE TO ADVANCE THE CATHETER/NEEDLE. THE HCP THEN WITHDREW THE CATHETER/NEEDLE AND CHECK THEM, AND FOUND THAT THE CATHETER TIP WAS SPLIT (DAMAGED)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11060627 ↗
• MalfunctionJul 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 24 GA 0.75 IN EXPERIENCED BLOOD EXPSOURE/SPLASH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT BLOOD LEAKAGE AND SPLASH OCCURRED WHEN HCP WITHDREW THE NEEDLE AFTER SUCCESSFUL NEEDLE PLACEMENT AT HCU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254484 ↗
• MalfunctionJul 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD SPLASH OCCURRED WHEN TOURNIQUET WAS RELEASED AND NEEDLE WAS WITHDRAWN WITH A BD CATHENA¿ SAFETY IV CATHETER. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE , HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CUSTOMER REPORTED THAT BLOOD SPLASH OCCURRED WHEN THE TOURNIQUET WAS RELEASED AND THE NEEDLE WAS WITHDRAWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10253493 ↗
• MalfunctionJan 29, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY SAFETY ACTIVATION FAILURE. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAFETY SYSTEM DID NOT ENGAGE WHEN THE CATHETER WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9643702 ↗
• MalfunctionMar 6, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT BD CATHENA¿ SAFETY IV CATHETER THE ANTI REFLEX VALVE DOES NOT FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION AND THERE WAS BLOOD LEAKING PAST THE VALVE AND OUT OF THE HUB. INSERTION WAS OBSERVED ON LIVE PATIENT, STEPS FOR INSERTION WERE PERFORMED CORRECTLY, AND AS SOON AS THE NEEDLE WAS PULLED OUT OF THE HUB, THE BLOOD WOULD LEAK UP BY FOLLOWING THE SPRING INSIDE THE CATHETER HUB. CONNECTION WITH A SALINE FLUSH WAS PERFORMED, AFTER DISCONNECTION, CATHETER LEAKED = VALVE NOT FUNCTIONING EITHER. REPEATED THIS TWICE, WITH THE SAME RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8395589 ↗
• MalfunctionMar 6, 2019Fluid/Blood Leak; Defective Component

  IT WAS REPORTED THAT BD CATHENA¿ SAFETY IV CATHETER THE ANTI REFLEX VALVE DOES NOT FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION AND THERE WAS BLOOD LEAKING PAST THE VALVE AND OUT OF THE HUB. INSERTION WAS OBSERVED ON LIVE PATIENT, STEPS FOR INSERTION WERE PERFORMED CORRECTLY, AND AS SOON AS THE NEEDLE WAS PULLED OUT OF THE HUB, THE BLOOD WOULD LEAK UP BY FOLLOWING THE SPRING INSIDE THE CATHETER HUB. CONNECTION WITH A SALINE FLUSH WAS PERFORMED, AFTER DISCONNECTION, CATHETER LEAKED = VALVE NOT FUNCTIONING EITHER. REPEATED THIS TWICE, WITH THE SAME RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8395584 ↗
• MalfunctionMar 5, 2019Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE CATHENA 24GX0.75IN STRAIGHT BC THE CATHETER ANTI REFLEX VALVE DOES NOT FUNCTION AFTER INSERTION OR CONNECTION/DISCONNECTION AND THERE WAS LEAKING PAST THE VALVE AND OUT OF THE HUB. THERE WERE 2 OCCURRENCES.

  Patient problems: No Information

  MAUDE report 8390825 ↗