BD Nexiva 383557Recalls & reported problems
Becton, Dickinson And Company · NEXIVA 20 GA X 1.25IN SP WITH MAXZERO · Class 2
Quick summary
This BD Nexiva IV catheter has 93 reports, 2 of them injuries, and no deaths. Common reports describe fluid leaking at the seal area, parts separating or being hard to separate, and contamination. 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
- 90
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00382903835577), received between Feb 19, 2018 and Jul 10, 2026 — classified as 2 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (24 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash24
- Material Separation15
- Difficult or Delayed Separation9
- Separation Problem8
- Retraction Problem7
- Device Contamination with Chemical or Other Material5
- Crack4
- Material Puncture/Hole4
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- No Known Impact Or Consequence To Patient8
- Pain2
- Perforation of Vessels2
- Blood Loss1
- Bruise/Contusion1
- Extravasation1
- Hemolysis1
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026
PATIENT WAS BROUGHT TO ED FOR INTERMITTENT RLQ [RIGHT LOWER QUADRANT] ABDOMINAL PAIN FOR 3 DAYS. PER ED-MD'S NOTES: PATIENT WILL NEED ADMISSION FOR FURTHER WORKUP AND MANAGEMENT; ADMITTED IN STABLE CONDITION. PATIENT NEEDED IV FLUIDS AS ORDERED BY MD. AS THEY WERE INSERTING THE IV, THEY NOTICED THAT THERE WAS FLUID ON THE RN'S GLOVES. FURTHER INVESTIGATION SHOWED A LEAK AT THE SEAL AREA. DEVICE WAS EXCHANGED FOR ANOTHER SIMILAR DEVICE, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS, BD NEXIVA (PER SITE REPORTER) THE SUPPLIES WITH THE SAME LOT NUMBERS HAVE BEEN GIVEN TO MATERIALS MANAGEMENT MANAGER BY ED-RN MANAGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25778527 ↗MalfunctionJul 10, 2026
PATIENT WAS IN INTERVENTIONAL RADIOLOGY DEPARTMENT INITIALLY TO HAVE PARACENTESIS; HOWEVER, PATIENT WAS NOTED TO HAVE HYPOTENSION BP 89/60 AND WAS BROUGHT TO ED. PATIENT NEEDED IV FLUIDS AS ORDERED BY ED-MD AND REFERRED TO HOSPITALIST FOR ADMISSION/ FURTHER ASSESSMENT. WHEN IV FLUID WAS INSERTED, RN NOTED FLUID DRIPPING ON TO HER GLOVES. IV WAS HALTED AND UPON CLOSER INVESTIGATION, LEAKAGE WAS NOTED AT THE SEAL AREA. DEVICE WAS EXCHANGED FOR ANOTHER SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT HARM. MANUFACTURER RESPONSE FOR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS, BD NEXIVA (PER SITE REPORTER) SUPPLIES WITH THE SAME LOT NUMBER HAVE BEEN GIVEN TO MATERIALS MANAGEMENT MANAGER BY ED RN MANAGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25778438 ↗MalfunctionFeb 9, 2026Material Integrity Problem
MalfunctionJan 22, 2026Crack; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152313 ↗MalfunctionJan 21, 2026Material Integrity Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131571 ↗MalfunctionJan 7, 2026Leak/Splash; Material Deformation
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23998805 ↗MalfunctionDec 5, 2025Leak/Splash; Leak/Splash
INJURIES OR ADVERSE EVENT: YES, REPORTED ISSUE: LEAKING FROM CRACK IN TUBING. 11/17/25: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025. 2. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? IV STARTED ON PATIENT WITH NO DIFFICULTY. BLOOD RETURNED THROUGH ATTACHED TUBING ON IV CATHETER AND RN NOTICED BLOOD DRIPPING AROUND TUBING. RN ATTACHED LR AND STARTED INFUSING TO OBSERVE IF IT WAS APPARENT WHERE DRIPPING WAS COMING FROM. LR NOTED TO BE LEAKING FROM CRACK IN TUBING. RN HAD TO DISCONTINUE THIS IV D/T MALFUNCTION IN TUBING. AN ADDITIONAL IV NEEDED TO BE STARTED CAUSING DISCOMFORT TO PT. 3. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? LACTATED RINGERS. 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. YES, THE PATIENT REQUIRES AN REPLACEMENT IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730425 ↗MalfunctionOct 23, 2025Leak/Splash; Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364465 ↗MalfunctionJul 7, 2025Contamination; Contamination
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO FOREIGN MATTER IN/ON A FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025 CONCERN DESCRIPTION: STAFF COMPLETING PRE CHECK OF IV CATHETER PRIOR TO INSERTION, NOTED A DISCOLORATION ON THE NEEDLE INSIDE THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411120 ↗MalfunctionMay 29, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT: ON (B)(6) 2025 CONCERN DESCRIPTION: BLOOD LEAKING FROM TUBING ONCE INSERTED INTO PATIENT VEIN (POSSIBLE PUNCTURE IN TUBING OR HOLE). CUSTOMER RESPONDED ON (B)(6). PATIENT REQUIRED A SECOND INSERTED PIV AS A RESULT OF FAULTY NEXIVA PIV CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22107223 ↗MalfunctionMar 25, 2025Fluid/Blood Leak; Material Separation; Free or Unrestricted Flow; Fluid/Blood Leak; Material Separation; Free or Unrestricted Flow
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO TUBING PARTIALLY SEPARATED FROM HUB; LEAKED AND DREW AIR DURING LAB DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE INSERTED IV AND IMMEDIATELY AFTERWARD WENT TO DRAW BLOODWORK. NOTED THAT ++ AIR WAS BEING SIPHONED. ASSESSED IV CATHETER SYSTEM AND NOTED THAT THE AREA BETWEEN THE DISTAL PINK HUB AND TUBING WAS PARTIALLY DISCONNECTED AND LEAKING BLOOD. DELAY IN PATIENT CASE REMOVED AND NEW IV INSERTED (ADDITIONAL COST).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21690477 ↗MalfunctionMar 4, 2025Separation Problem; Separation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21519017 ↗MalfunctionMar 4, 2025Separation Problem; Separation Problem
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21519012 ↗MalfunctionMar 4, 2025
RN WAS STARTING AN IV AND WAS PERFORMING THE NECESSARY STEPS PRIOR TO USE. ISSUE: GRAY PUSH TAB WON'T DISENGAGE FROM NEEDLE SHIELD. NO PATIENT INVOLVEMENT. MANUFACTURER RESPONSE FOR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS, BD NEXIVA (PER SITE REPORTER). BD FIELD REPRESENTATIVE MADE AWARE [(B)(6)].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21513766 ↗InjuryFeb 11, 2025Leak/Splash; Leak/Splash
MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash
MATERIAL # 383557 BATCH # UNKNOWN IT WAS REPORTED THAT THE BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PATIENT WAS REQUIRING EXCESSIVE DOSES OF PROPOFOL AND STILL NOT SETTLING. IT WAS FINALLY IDENTIFIED THAT THE CAP WAS LEAKING DESPITE BEING APPLIED APPROPRIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21328131 ↗MalfunctionJan 28, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO UNABLE TO PULL THE NEEDLE APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 383557. BATCH # 4193548. IT WAS REPORTED BY CUSTOMER THAT UNABLE TO PULL WHITE AND GREY APART TO BREAK THE SEAL. VERBATIM: UNABLE TO PULL WHITE AND GREY APART TO BREAK THE SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252886 ↗MalfunctionNov 22, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN 3 INSTANCES WHERE THE CATHETER WILL NOT SEPARATE FROM THE NEEDLE. ALL 20G, ALL IN THE ER, AND ALL LOT#4193548. ONE CATHETER HAS BEEN SEQUESTERED AT THIS TIME AND THEY ARE GOING TO KEEP ME UPDATED IF THERE ARE ANY MORE ISSUES. (B)(6). 1. WHAT IS THE DATE OF EVENT? 11/1/2024. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT: PATIENT REQUIRED ADDITIONAL STICK FOR IV PLACEMENT. (B)(6). I HAVE AN UPDATE ON THIS QUESTION AFTER SEEING THE IMPACTED PRODUCT: 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT: NO HARM. UNABLE TO SEPARATE THE CATHETER FROM THE NEEDLE. NEVER USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20761051 ↗MalfunctionOct 30, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS SUPER DIFFICULT TO RETRACT AND WILL ACTUALLY GRIND WHILE FORCING A RETRACTION. IN SOME INSTANCES THE FORCE THAT HAS HAD TO BE USED TO RETRACT THE NEEDLE HAS CAUSED A PUNCTURE IN THE TUBING WHICH THEN LEAKS AND WE HAVE TO RE-STICK THE PATIENT. INJURIES OR ADVERSE EVENT: NO ONLY PATIENT HARM IS HAVING TO BE STUCK AGAIN WITH AN IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20566398 ↗MalfunctionOct 27, 2024Difficult or Delayed Activation; Difficult or Delayed Separation; Difficult or Delayed Activation; Difficult or Delayed Separation
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541445 ↗MalfunctionOct 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO NEEDLE DISENGAGEMENT DIFFICULTIES RESULTED IN NEEDLE PIERCING THE CATHETER AND BLOOD LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS SUPER DIFFICULT TO RETRACT AND WILL ACTUALLY GRIND WHILE FORCING A RETRACTION. IN SOME INSTANCES, THE FORCE THAT HAS HAD TO BE USED TO RETRACT THE NEEDLE HAS CAUSED A PUNCTURE IN THE TUBING WHICH THEN LEAKS AND WE HAVE TO RE-STICK THE PATIENT. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20541345 ↗MalfunctionOct 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO NEEDLE DISENGAGEMENT DIFFICULTY RESULTING IN PIERCED CATHETER AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DESCRIPTION: DIFFICULT TO RETRACT. REPORTED ISSUE: THE NEEDLE IS SUPER DIFFICULT TO RETRACT AND WILL ACTUALLY GRIND WHILE FORCING A RETRACTION. IN SOME INSTANCES, THE FORCE THAT HAS HAD TO BE USED TO RETRACT THE NEEDLE HAS CAUSED A PUNCTURE IN THE TUBING WHICH THEN LEAKS AND WE HAVE TO RE-STICK THE PATIENT. INJURIES OR ADVERSE EVENT: NO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540993 ↗MalfunctionOct 27, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO NEEDLE DISENGAGEMENT DIFFICULTY RESULTING IN PIERCED CATHETER AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DESCRIPTION: DIFFICULT TO RETRACT. REPORTED ISSUE: THE NEEDLE IS SUPER DIFFICULT TO RETRACT AND WILL ACTUALLY GRIND WHILE FORCING A RETRACTION. IN SOME INSTANCES, THE FORCE THAT HAS HAD TO BE USED TO RETRACT THE NEEDLE HAS CAUSED A PUNCTURE IN THE TUBING WHICH THEN LEAKS AND WE HAVE TO RE-STICK THE PATIENT. INJURIES OR ADVERSE EVENT: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540992 ↗MalfunctionOct 14, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTEMPTING TO REMOVE THE NEEDLE, THEY TEND TO GET STUCK AND ARE DIFFICULT TO EXTRACT. INJURIES OR ADVERSE EVENT: NO. (B)(6) 2024. THIS HAS HAPPENED THROUGHOUT THE MONTH OF SEPTEMBER; I DO NOT HAVE EXACT DATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440467 ↗MalfunctionSep 29, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT BD NEXIVA 20 GA X 1.25IN SP WITH MAXZERO HAD A HOLE IN THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS HAPPENED ON (B)(6) 2024 WHEN RN WENT TO START AND IV AND NOTICED WHILE ADVANCING CATHETER. THE END OF THE CATHETER CRINKLED UP AND SHE NOTICED A HOLE IN THE SIDE OF THE CATHETER ABOUT HALFWAY UP THE NEEDLE. I ASKED IF SHE ATTEMPTED TO RE SHEATH THE NEEDLE AT ANY TIME AND SHE DID NOT. (B)(6) 2024, ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO ADVERSE EVENT OR INJURY TO THE PATIENT OR RN. PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20330132 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.