BD Nexiva 383511Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 00382903835119), received between Dec 20, 2017 and Sep 24, 2026 — classified as 5 injuries, 181 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (71 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 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884802 ↗
• MalfunctionMay 12, 2026Nonstandard Device

  IT WAS REPORTED BY THE CUSTOMER THAT THE IV KITS ARE PRODUCING PAIN AND DISCOMFORT. PLASTIC PIECE ON TOP OF IV IS BREAKING OFF. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED STAFF IS REPORTING THAT THE IV KITS ARE PRODUCING PAIN AND DISCOMFORT. PLASTIC PIECE ON TOP OF IV IS BREAKING OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149584 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED BY CUSTOMER THAT THEY DEAL WITH ITEMS BREAKING UPON USE AND PATIENT DISCOMFORT VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED THE BELOW QUALITY COMPLAINT FROM OUR END USER AND THEY HAVE PULLED THE PRODUCT FROM THEIR SHELVES. PLEASE PROVIDE A RETURN AUTHORIZATION/ SHIPPING LABELS FOR THE BELOW PRODUCT. (B)(6) ITEM NUMBER 383511 QTY/UM - (B)(4) EA LOT NUMBER - 5297500 ISSUE - CUSTOMER HAS DEALT WITH ITEMS BREAKING UPON USE AND PATIENT DISCOMFORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113473 ↗
• MalfunctionApr 27, 2026Leak/Splash

  IT WAS REPORTED BY A CUSTOMER THAT THE CONNECTION STOP IS NOT CONNECTED WHICH PREVENTS THE BLOOD/ FLUID FROM JUST FLOWING OUT OF THE LINE. VERBATIM: "THE ISSUE IS: THIS IS AT LEAST THE 5TH ONE OF THESE THAT THE CONNECTION STOP IS NOT CONNECTED. THIS PREVENTS THE BLOOD/ FLUID FROM JUST FLOWING OUT OF THE LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000152 ↗
• MalfunctionApr 20, 2026Nonstandard Device

  IT WAS REPORTED BY CUSTOMER THAT THE IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHING FORWARD TO ADVANCE INTO VEIN. NOTED HOLE ON SIDE OF IV CANNULA AND CROOKED CANNULA UPON REMOVAL. COMPLAINT VIA EMAIL. MEDICAL DEVICE INCIDENT REPORT TO VENDOR REQUEST FOR INVESTIGATION AND COMPLAINTS/LOT REVIEW MDIP # (B)(4) DEVICE AVAILABLE FOR INVESTIGATION: YES PLEASE SEE THE BELOW DEVICE PROBLEM REPORT. THERE WAS NO SERIOUS HARM REPORTED. THE DEVICE IS AVAILABLE FOR INVESTIGATION (ADDITIONAL DETAILS BELOW). MDIP REPORT: INCIDENT OR PROBLEM INFORMATION MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026 TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: TEMPORARY HARM. OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: INITIATING IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927313 ↗
• MalfunctionApr 20, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHING FORWARD TO ADVANCE INTO VEIN. NOTED HOLE ON SIDE OF IV CANNULA AND CROOKED CANNULA UPON REMOVAL. COMPLAINT VIA EMAIL. MEDICAL DEVICE INCIDENT REPORT TO VENDOR REQUEST FOR INVESTIGATION AND COMPLAINTS/LOT REVIEW MDIP # (B)(4). DEVICE AVAILABLE FOR INVESTIGATION: YES, PLEASE SEE THE BELOW DEVICE PROBLEM REPORT. THERE WAS NO SERIOUS HARM REPORTED. THE DEVICE IS AVAILABLE FOR INVESTIGATION (ADDITIONAL DETAILS BELOW). MDIP REPORT INCIDENT OR PROBLEM INFORMATION MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026. TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: TEMPORARY HARM OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: INITIATING IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927300 ↗
• MalfunctionApr 20, 2026Material Puncture/Hole

  IT WAS REPORTED BY CUSTOMER THAT THE IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHING FORWARD TO ADVANCE INTO VEIN. NOTED HOLE ON SIDE OF IV CANNULA AND CROOKED CANNULA UPON REMOVAL. VERBATIM: COMPLAINT VIA EMAIL. MEDICAL DEVICE INCIDENT REPORT TO VENDOR REQUEST FOR INVESTIGATION AND COMPLAINTS/LOT REVIEW: MDIP # (B)(4). DEVICE AVAILABLE FOR INVESTIGATION: YES. PLEASE SEE THE BELOW DEVICE PROBLEM REPORT. THERE WAS NO SERIOUS HARM REPORTED. THE DEVICE IS AVAILABLE FOR INVESTIGATION (ADDITIONAL DETAILS BELOW). MDIP REPORT. INCIDENT OR PROBLEM INFORMATION: MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026. TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: TEMPORARY HARM. OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: INITIATING IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927297 ↗
• MalfunctionDec 18, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT CATHETER WAS DEFECTIVE/ DAMAGED THE CANNULA SEEMED TO SPLIT. DURING USE IT WAS REPORTED THAT WHILE CANNULATING, THE NEEDLE SLIPPED OUT OF THE CANNULA WHILE THE CANNULA WAS IN THE VEIN. THE CANNULA SEEMED TO SPLIT IN TWO. THE PUNCTURE WOUND BECAME BIG.

  Patient problems: Laceration(s)

  MAUDE report 23842551 ↗
• MalfunctionDec 18, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  INCIDENT DATE: ON (B)(6) 2025. DETAILS OF COMPLAINT (REPORTED ISSUE): "ONCE I FLUSHED THE PIV, I NOTICED THERE WAS A HOLE/CRACK IN THE TUBING." COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840226 ↗
• MalfunctionDec 18, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT CATHETER WAS DEFECTIVE AND LEAKED IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A HOLE IN THE CATHETER. IV HAD TO BE REMOVED FROM PATIENT, AND PATIENT RE-POKED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. (B)(6) COMPLAINT REFERENCE #: (B)(4) HOSPITAL COMPLAINT REFERENCE #: (B)(4) CORRESPONDENCE LANGUAGE: ENGLISH CAT# OF PRODUCT BEING COMPLAINED: (B)(4) DESCRIPTION OF PRODUCT: CATHETER S-PORT 24GAX0.75IN NEXIVA 20EA/BX 4BX/CA LOT OR S/N: (B)(6) COMPLAINT CATEGORY: DAMAGED / BROKEN INCIDENT DATE: (B)(6) 2025. HOSPITAL COMPLAINT REFERENCE #: (B)(4) DETAILS OF COMPLAINT (REPORTED ISSUE): "UPON FURTHER INSPECTION, RN NOTED THAT THERE WAS A HOLE IN THE CATHETER. IV HAD TO BE REMOVED FROM PATIENT, AND PATIENT RE-POKED." ADDITIONAL INFORMATION ATTACHED. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS (B)(6) BEEN INFORMED? UNKNOWN QTY AFFECTED: (B)(4) EA SAMPLES AVAILABLE? YES, IS CUSTOMER REQUESTING AN RGA? NO RETURN QTY: QTY SAMPLES: (B)(4) EA IV INSERTED INTO PATIENT, WHEN RN WITHDREW THE NEEDLE FROM THE CANNULA, BLOOD BEGAN POOLING AT THE IV INSERTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840210 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT ON THE FOURTH DAY AFTER PLACEMENT, A DRUG LEAK OCCURRED FROM THE EXTENSION TUBE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581961 ↗
• MalfunctionNov 4, 2025Contamination; Contamination

  THIS IS A COMPLAINT ABOUT FOREIGN-BODY ADHESION BEFORE USE. IT WAS REPORTED THAT BLACK, RESIDUE-LIKE MATERIAL ADHERING TO THE CATHETER PORTION BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466645 ↗
• MalfunctionOct 27, 2025Leak/Splash; Leak/Splash

  THIS IS A COMPLAINT ABOUT BLOOD LEAKED FROM THE CATHETER DURING USE. IT WAS REPORTED THAT BLOOD LEAK OCCURS IMMEDIATELY AFTER CATHETER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398120 ↗
• MalfunctionSep 9, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT - SAFETY SHIELD ACTIVATION FAILURE. IT WAS REPORTED THAT WHEN THE NEXIVA WAS PUNCTURED INTO THE PATIENT AND THE INNER TUBE WAS WITHDRAWN, THE SAFETY MECHANISM DID NOT WORK AND THE GRAY COMPONENT FELL OUT, EXPOSING THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005298 ↗
• MalfunctionSep 2, 2025Crack; Crack

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940340 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT BD NEXIVA SINGLE PORT CLAMP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE CLAMP BROKE WHILE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500379 ↗
• MalfunctionJun 13, 2025Leak/Splash; Leak/Splash

  DESCRIPTION: THIS IS A COMPLAINT ABOUT CATHETER DAMAGE. IT WAS REPORTED THAT A PERIPHERAL VENOUS CATHETER WAS PLACED USING NEXIVA 24G. WHEN THE CATHETER WAS ADVANCED, IT FELT STIFFER THAN USUAL, AND WHEN THE CATHETER WAS ADVANCED COMPLETELY, BLOOD BEGAN TO LEAK FROM NEAR THE INSERTION SITE. THE CATHETER WAS PULLED BACK SLIGHTLY TO CHECK WHERE THE BLOOD WAS LEAKING FROM, AND IT WAS FOUND TO BE LEAKING FROM THE CONNECTION BETWEEN THE CATHETER AND THE FIXATION WING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202337 ↗
• MalfunctionApr 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT DAMAGED EXT TUBING AND LEAKED THIS IS A COMPLAINT ABOUT EXTENSION TUBE DAMAGED DURING USE. IT WAS REPORTED THAT ON 16TH APRIL WHEN THE CUSTOMER ATTEMPTING TO SECURE THE CONNECTOR BY PRESSING IN A CLAMP, IT SLIPPED AND CUT THE EXTENSION TUBE WITH THE EDGE OF THE CLAMP, RESULTING IN A LEAK OF LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936074 ↗
• MalfunctionApr 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT TUBING WAS DEFECTIVE/ DAMAGED IT WAS A REPORT ABOUT BROKEN EXTENSION TUBE. THE PLACEMENT WAS DONE ON 4/8, THERE WAS NO PROBLEM AT 4/16 16:00, BUT WHEN LOOKED AT IT AT 22:00, IT WAS FOUND THAT THE DRUG SOLUTION WAS LEAKING OUT FROM THE MIDDLE OF THE EXTENSION TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927661 ↗
• MalfunctionApr 18, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT BD NEXIVA 24 GA X 3/4 IN SINGLE PORT LABEL CONTENT INCORRECT THIS IS A COMPLAINT ABOUT THE ¿SIZE IDENTIFICATION COLOR¿ PRINTED ON THE BACK OF THE INDIVIDUAL PACKAGING IS DIFFERENT. WHEN SORTING AT THE HOSPITAL SPD, CUSTOMER NOTICED THAT THE ¿SIZE IDENTIFICATION COLOR¿ FOR 24G PRINTED ON THE BACK OF THE INDIVIDUAL PACKAGING SHOULD BE YELLOW, BUT 12 OF THE 20 ITEMS (1 SP) ARE PRINTED IN GREEN (SAME COLOR AS 18G). THE OTHER 8 ITEMS ARE YELLOW, AND THE LOT NUMBERS WITHIN THIS 1 SP ARE ALL THE SAME (BOTH GREEN AND YELLOW).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868589 ↗
• MalfunctionApr 17, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855900 ↗
• MalfunctionMar 5, 2025Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529832 ↗
• MalfunctionJan 29, 2025Separation Problem; Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270139 ↗
• MalfunctionJan 24, 2025Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233595 ↗
• MalfunctionDec 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE CAME OUT OF HOUSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AHS MDIP REFERENCE NUMBER (ID): (B)(4). LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. INCIDENT DETAILS: WHEN LOOSENING THE NEEDLE FROM THE CATHLON (STANDARD PRACTICE), THE NEEDLE FELL OUT OF THE NEXIVA. THIS HAPPENED TWICE. TYPICALLY, THE NEEDLE NEEDS TO BE MANUALLY PULLED OUT AND THE SAFETY WILL ENGAGE. WHO WAS AFFECTED? NO PERSON AFFECTED. (B)(6) THE ISSUE HAPPENED WHEN PREPPING THE IV, BEFORE TOUCHING THE PATIENT. TYPICALLY, THE NEEDLE NEEDS TO BE LOOSENED FROM THE CATHLON (SO IT CAN BE EASILY ADVANCED INTO THE VEIN). TO LOOSEN IT YOU PULL THE NEEDLE BACK AND THEN PUSH IT BACK IN. THIS IS WHAT I WAS IN THE PROCESS OF DOING WHEN THE NEEDLE FELL OUT ENTIRELY, AND THE SAFETY DID NOT ENGAGE. THE SAFETY WAS STILL ATTACHED TO THE CATHLON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854972 ↗