BD Cathena™ Safety IV Catheter 386865Recalls & reported problems
Becton, Dickinson And Company · US CATHENA 18GX1.25IN 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 intravenous line used for injecting fluids and withdrawing blood. The 38 reports mostly describe leaking: blood or fluid escaping from the catheter hub or valve, sometimes spraying onto patients, staff and floors, along with safety locks that fail to engage and material or lubricant inside the catheter. No deaths and no injuries are reported. There are no recalls naming this device. Reports have slowed sharply, from 25 in the earlier 12 months to 4 in the most recent 12 months.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00382903868650), received between Dec 9, 2021 and Jun 22, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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
- Fluid/Blood Leak17
- Leak/Splash10
- Retraction Problem4
- Activation Problem3
- Material Protrusion/Extrusion3
- Activation Failure2
- Nonstandard Device2
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Fluid/Blood Leak; Nonstandard Device
IT WAS REPORTED BY A CUSTOMER THAT THE IVS WHERE THE VALVE FAILED, RESULTING IN BLOOD FLOWING ONTO THE PATIENT, NURSE AND FLOOR. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I JUST WANTED TO EMAIL AND LET YOU KNOW WE HAVE HAD MORE IVS WHERE THE VALVE FAILED, RESULTING IN BLOOD FLOWING ONTO THE PATIENT, NURSE AND FLOOR. THIS HAS ALREADY HAPPENED TWICE THIS WEEK WITH TWO DIFFERENT NURSES. ONE WAS A 20G AND THE OTHER WAS AN 18G. I RECOVERED THE 18G PACKAGE. LOT NUMBER 5170365. HERE IS A PIR FOR (B)(6). I DO NOT HAVE THE AFFECTED PRODUCT BUT DO HAVE ONE LOT NUMBER. BOTH INSTANCES THE VALVE FOR BLOOD CONTROL FAILED. DATE OF OCCURRENCE: 6/3/26 386884 20 G X 1 386865 18G X 1.25 (LOT NUMBER 5170365) ADDITIONAL INFORMATION RECEIVED ON 12JUN2026: THE IV INCIDENTS DID NOT OCCUR ON THE SAME DAY. THESE INCIDENTS REQUIRED THE PATIENT TO BE STUCK AGAIN AND CAUSED BLOOD EXPOSURE TO THE NURSES. WE CURRENTLY HAVE SEVERAL ISSUES WITH IVS LEAKING FROM THE HUB CONNECTED TO THE END OF THE IV EVEN AFTER WE MAKE SURE IT IS SECURED AND ATTACHED PROPERLY. THIS RESULTS IN PATIENTS NOT RECEIVING ALL THEIR IV MEDICATIONS, REQUIRING REPEAT NEEDLE STICKS, AND CAUSING BODILY FLUID EXPOSURE. THIS HAPPENED JUS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578791 ↗MalfunctionJun 16, 2026Fluid/Blood Leak; Leak/Splash; Nonstandard Device
IT WAS REPORTED BY A CUSTOMER THAT THE IVS WHERE THE VALVE FAILED, RESULTING IN BLOOD FLOWING ONTO THE PATIENT, NURSE AND FLOOR. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I JUST WANTED TO EMAIL AND LET YOU KNOW WE HAVE HAD MORE IVS WHERE THE VALVE FAILED, RESULTING IN BLOOD FLOWING ONTO THE PATIENT, NURSE AND FLOOR. THIS HAS ALREADY HAPPENED TWICE THIS WEEK WITH TWO DIFFERENT NURSES. ONE WAS A 20G AND THE OTHER WAS AN 18G. I RECOVERED THE 18G PACKAGE. LOT NUMBER 5170365. HERE IS A PIR FOR BAPTIST HEALTH. I DO NOT HAVE THE AFFECTED PRODUCT BUT DO HAVE ONE LOT NUMBER. BOTH INSTANCES THE VALVE FOR BLOOD CONTROL FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523295 ↗MalfunctionMay 13, 2026Activation Failure
IT WAS REPORTED BY THE CUSTOMER THAT SAFETY LOCK FAILED TO ENGAGE AFTER INSERTION. VERBATIM PRODUCT BD CATHENA IV CATHETER, 18G, 1.25 IN ISSUE SAFETY LOCK FAILED TO ENGAGE AFTER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163547 ↗MalfunctionMay 8, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THEY PULLED THE NEEDLE BACK AND OUT, THE SAFETY MECHANISM DIDN'T ENGAGE, AND SHE POKED HER RIGHT FINGER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PLEASE REVIEW AND PROVIDE A RESPONSE TO THE PRODUCT QUALITY ISSUE REPORTED. PLEASE CONTACT THE FACILITY DIRECTLY FOR DETAILS, SAMPLE COLLECTION AND RESOLUTION. WHEN THE INVESTIGATION HAS COMPLETED, PLEASE PROVIDE XXX WITH A COPY OF THE FINAL LETTER IN ORDER TO CLOSE OUT THE TICKET IN THE XXX DATABASE. I WILL FOLLOW UP WITH YOU FOR A STATUS UPDATE IN A COUPLE OF WEEKS. FACILITY CONTACT: XXX DEPARTMENT: MATERIALS MANAGEMENT PHONE NUMBER: XXX EMAIL: XXXX PRODUCT CATALOG NUMBER:386865 PRODUCT DESCRIPTION: CATHETER INTRAVENOUS STRAIGHT CATHENA PERIPHERAL STERILE LTX-FREE DISPOSABLE US 18GX1.25IN BC ORIGIN OF THE ISSUE: OTHER DETAIL: RN WAS USING CATHETER TO START IV ON PT, WHEN SHE PULLED THE NEEDLE BACK AND OUT, THE SAFETY MECHANISM DIDN'T ENGAGE, AND SHE POKED HER RIGHT FINGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125757 ↗MalfunctionJul 21, 2025Contamination; Contamination
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT ADDITIONAL PIECE OF LUBRICATION IN CATHETER VERBATIM: ADDITIONAL PIECE OF LUBRICATION IN CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22557561 ↗MalfunctionJun 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC LEAKED IT WAS REPORTED BY THE CUSTOMER THAT PRODUCT LEAKAGE THROUGH THE SEPTUM. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 4/21/25 BD ISSUED A MEDICAL DEVICE PRODUCT REMOVAL TO ADDRESS THE REPORTED ISSUE OF PRODUCT LEAKAGE THROUGH THE SEPTUM. THIS NOTIFICATION AFFECTED PRESOURCE RAW MATERIAL INVENTORY AND/OR FINISHED GOODS. AS A RESULT, A SUPPLIER CORRECTIVE ACTION REQUEST IS BEING ISSUED FOR ROOT CAUSE INVESTIGATION AND CORRECTIVE/PREVENTIVE ACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304495 ↗MalfunctionMay 29, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE BD US CATHENA 18GX1.25IN STRAIGHT BC HAD A BLOOD LEAK OUT OF THE CONTROL PLUG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 386865, BATCH#: 4304891. VERBATIM: FAILED BLOOD CONTROL VALVE. BLOOD EXPOSURE TO CLINICIAN, IV TAKEN OUT OF PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104704 ↗MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT THE BLOOD CONTROL VALVE NOT WORKING, BLOOD IS LEAKING FROM HUB OF PIV. VERBATIM: BLOOD CONTROL VALVE NOT WORKING, BLOOD LEAKING FROM HUB OF PIV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969388 ↗MalfunctionApr 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT A PIECE OF PLASTIC WAS OBSERVED AT THE TIP OF THE NEEDLE AND CATHETER VERBATIM: A PIECE OF PLASTIC WAS OBSERVED AT THE TIP OF THE NEEDLE AND CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21891766 ↗MalfunctionApr 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC LEAKED IT WAS REPORTED BY CUSTOMER THAT CATHENA IV SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. THE GUARD TO PREVENT LEAKING/POTENTIAL NURSE EXPOSURE IS NOT WORKING. RCC RECEIVED A COMPLAINT VIA EMAIL. SEVERAL L&D [LABOR AND DELIVERY] RNS [REGISTERED NURSES] HAVE REPORTED TODAY AND JUST RECENTLY THAT THE BD CATHENA IV SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. THE GUARD TO PREVENT LEAKING/POTENTIAL NURSE EXPOSURE IS NOT WORKING. 20G - 25-30 PATIENTS, 18G - 20 PATIENTS, MANUFACTURER RESPONSE FOR IV CATHETER, CATHENA (PER SITE REPORTER), MEETING W BD AT THEIR REQUEST ON [REDACTED]: BD WAS ABLE TO REPLICATE THE FAILURE OF THE ANTI-REFLUX VALVE IN THE 20G AND 18G CATHENAS. SOMETIMES THIS CAN BE PRACTICE-RELATED REGARDING THE ¿NEEDLE PARKING,¿ BUT IN THIS CASE THERE WAS ALSO A PRODUCT DEFECT DETECTED. THE INVESTIGATION IS NOT FORMALLY CLOSED YET, BUT THERE SEEMS TO BE A SINGLE BATCH OF SEPTUMS WITH TEAR IN THE SEPTUM. UNKNOWN IF RECEIVED THIS WAY OR IF HAPPENED DURING THE ASSEMBLY PROCESS AT BD. [REDACTED] WILL FEEDBACK THE PRACTICE PIECE TO THE STAFF TO TRY TO ELIMINATE THAT FACTOR IN THE FUTURE. SO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21868592 ↗MalfunctionApr 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC LEAKED IT WAS REPORTED BY CUSTOMER THAT CATHENA IV SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. THE GUARD TO PREVENT LEAKING/POTENTIAL NURSE EXPOSURE IS NOT WORKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SEVERAL L&D [LABOR AND DELIVERY] RNS [REGISTERED NURSES] HAVE REPORTED TODAY AND JUST RECENTLY THAT THE BD CATHENA IV SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. THE GUARD TO PREVENT LEAKING/POTENTIAL NURSE EXPOSURE IS NOT WORKING. 20G - 25-30 PATIENTS 18G - 20 PATIENTS MANUFACTURER RESPONSE FOR IV CATHETER, CATHENA (PER SITE REPORTER) MEETING W BD AT THEIR REQUEST ON [REDACTED]: ¿ BD WAS ABLE TO REPLICATE THE FAILURE OF THE ANTI-REFLUX VALVE IN THE 20G AND 18G CATHENAS. O SOMETIMES THIS CAN BE PRACTICE-RELATED REGARDING THE ¿NEEDLE PARKING,¿ BUT IN THIS CASE THERE WAS ALSO A PRODUCT DEFECT DETECTED. ? THE INVESTIGATION IS NOT FORMALLY CLOSED YET, BUT THERE SEEMS TO BE A SINGLE BATCH OF SEPTUMS WITH TEAR IN THE SEPTUM. UNKNOWN IF RECEIVED THIS WAY OR IF HAPPENED DURING THE ASSEMBLY PROCESS AT BD. ? [REDACTED] WILL FEEDBACK THE PRACTICE PIECE TO THE STAFF TO TRY TO ELIMIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21868591 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC LEAKED IT WAS REPORTED BY CUSTOMER THAT CATHENA IV SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. THE GUARD TO PREVENT LEAKING/POTENTIAL NURSE EXPOSURE IS NOT WORKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DESCRIBE THE EVENT OR PROBLEM: SEVERAL L&D [LABOR AND DELIVERY] RNS [REGISTERED NURSES] HAVE REPORTED TODAY AND JUST RECENTLY THAT THE BD CATHENA IV SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. THE GUARD TO PREVENT LEAKING/POTENTIAL NURSE EXPOSURE IS NOT WORKING. 20G - 25-30 PATIENTS, 18G - 20 PATIENTS = MANUFACTURER RESPONSE FOR IV CATHETER, CATHENA (PER SITE REPORTER) = MEETING W BD AT THEIR REQUEST ON [REDACTED]: ¿ BD WAS ABLE TO REPLICATE THE FAILURE OF THE ANTI-REFLUX VALVE IN THE 20G AND 18G CATHENAS. SOMETIMES THIS CAN BE PRACTICE-RELATED REGARDING THE ¿NEEDLE PARKING,¿ BUT IN THIS CASE THERE WAS ALSO A PRODUCT DEFECT DETECTED. THE INVESTIGATION IS NOT FORMALLY CLOSED YET, BUT THERE SEEMS TO BE A SINGLE BATCH OF SEPTUMS WITH TEAR IN THE SEPTUM. UNKNOWN IF RECEIVED THIS WAY OR IF HAPPENED DURING THE ASSEMBLY PROCESS AT BD. [REDACTED] WILL FEEDBACK THE PRACTICE PIECE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860327 ↗MalfunctionApr 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT BLEED BACK AFTER INSERTION. THEY WERE ABLE TO REPLICATE THE FAILURE OF THE ANTI-REFLUX VALVE IN THE 20G AND 18G CATHENAS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DESCRIBE THE EVENT OR PROBLEM: #20 BD CATHETERS REF # (B)(4) BLEED BACK AFTER INSERTION. MANUFACTURER RESPONSE FOR IV CATHETER, CATHENA (PER SITE REPORTER): BD WAS ABLE TO REPLICATE THE FAILURE OF THE ANTI-REFLUX VALVE IN THE 20G AND 18G CATHENAS. SOMETIMES THIS CAN BE PRACTICE-RELATED REGARDING THE ¿NEEDLE PARKING,¿ BUT IN THIS CASE THERE WAS ALSO A PRODUCT DEFECT DETECTED. THE INVESTIGATION IS NOT FORMALLY CLOSED YET, BUT THERE SEEMS TO BE A SINGLE BATCH OF SEPTUMS WITH TEAR IN THE SEPTUM. UNKNOWN IF RECEIVED THIS WAY OR IF HAPPENED DURING THE ASSEMBLY PROCESS AT BD. [REDACTED] WILL FEEDBACK THE PRACTICE PIECE TO THE STAFF TO TRY TO ELIMINATE THAT FACTOR IN THE FUTURE. SO FAR, BD HAS IDENTIFIED 6 LOTS THAT CONTAINED THE FAULTY SEPTUMS. 2 OF THOSE LOTS WERE SHIPPED OUT TO DISTRIBUTORS AND MAY REACH CUSTOMERS. THE OTHER 4 LOTS WERE PROACTIVELY PLACED ON INTERNAL HOLD PENDING THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859658 ↗MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT THE CATHENA BLOOD CONTROL NOT WORKING. ALLOWING FOR BLOOD RETURN UPON PLACING IV CATHETER. VERBATIM: CATHENA BLOOD CONTROL NOT WORKING. ALLOWING FOR BLOOD RETURN UPON PLACING IV CATHETER BD REP RESPONSE ON (B)(6) 2025 FOR (B)(4): 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 2. IN (B)(4), THE LOT NUMBER WAS MENTIONED AS 4124016, BUT THE ATTACHED PRODUCT IMAGE SHOWS THE LOT NUMBER AS 4198480. COULD YOU PLEASE CONFIRM WHICH LOT IS EXPERIENCING THE REPORTED ISSUE, OR IF BOTH ARE AFFECTED? BOTH LOT NUMBERS ARE AFFECTED. CUSTOMER RESPONSE ON (B)(6) 2025. FOR (B)(4): 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858935 ↗MalfunctionApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC BLOOD LEAKS OUT OF CONTROL PLUG IT WAS REPORTED BY CUSTOMER THAT THE CATHENA BLOOD CONTROL NOT WORKING. ALLOWING FOR BLOOD RETURN UPON PLACING IV CATHETER. VERBATIM: CATHENA BLOOD CONTROL NOT WORKING. ALLOWING FOR BLOOD RETURN UPON PLACING IV CATHETER. BD REP RESPONSE ON 04-APR-2025 FOR PR (B)(6): 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 2. IN PIR (B)(6), THE LOT NUMBER WAS MENTIONED AS 4124016, BUT THE ATTACHED PRODUCT IMAGE SHOWS THE LOT NUMBER AS 4198480. COULD YOU PLEASE CONFIRM WHICH LOT IS EXPERIENCING THE REPORTED ISSUE, OR IF BOTH ARE AFFECTED? BOTH LOT NUMBERS ARE AFFECTED. CUSTOMER RESPONSE ON 07-APR-2025. FOR PR (B)(6): 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21858918 ↗MalfunctionMar 18, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT BD US CATHENA 18GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED. IT WAS REPORTED BY CUSTOMER THAT CATHENA NEEDLE NOT SAFETYING. VERBATIM: CATHENA NEEDLE NOT SAFETYING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634478 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 18G SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. COULD YOU PLEASE CONFORM THE NUMBER OF OCCURRENCES FOR 18 GAUGE? APPROXIMATELY 20 IT WAS MENTIONED AS "ISSUE REPORTED BY 4 RN", KINDLY CONFORM THE NUMBER OF PATIENTS INVOLVED 18G 20 PATIENTS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597266 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597264 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597261 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 18G SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. COULD YOU PLEASE CONFORM THE NUMBER OF OCCURRENCES FOR 18 GAUGE? APPROXIMATELY 20. IT WAS MENTIONED AS "ISSUE REPORTED BY 4 RN", KINDLY CONFORM THE NUMBER OF PATIENTS INVOLVED 18G 20 PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597251 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 18G SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. COULD YOU PLEASE CONFORM THE NUMBER OF OCCURRENCES FOR 18 GAUGE? APPROXIMATELY 20. IT WAS MENTIONED AS "ISSUE REPORTED BY 4 RN", KINDLY CONFORM THE NUMBER OF PATIENTS INVOLVED 18G 20 PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597249 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 18G SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. COULD YOU PLEASE CONFORM THE NUMBER OF OCCURRENCES FOR 18 GAUGE? APPROXIMATELY 20. IT WAS MENTIONED AS "ISSUE REPORTED BY 4 RN", KINDLY CONFORM THE NUMBER OF PATIENTS INVOLVED 18G 20 PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597229 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 18G SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. COULD YOU PLEASE CONFORM THE NUMBER OF OCCURRENCES FOR 18 GAUGE? APPROXIMATELY 20 IT WAS MENTIONED AS "ISSUE REPORTED BY 4 RN", KINDLY CONFORM THE NUMBER OF PATIENTS INVOLVED 18G 20 PATIENTS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597223 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597208 ↗MalfunctionMar 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD US CATHENA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 18G SAFETY CATHETERS HAVE BEEN LEAKING WHEN THE IV IS STARTED. COULD YOU PLEASE CONFORM THE NUMBER OF OCCURRENCES FOR 18 GAUGE? APPROXIMATELY 20. IT WAS MENTIONED AS "ISSUE REPORTED BY 4 RN", KINDLY CONFORM THE NUMBER OF PATIENTS INVOLVED 18G 20 PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597204 ↗
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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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