IV Administration Set V1921Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 04046964188558), received between Dec 2, 2016 and Sep 25, 2026 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Leak/Splash

  As reported by the user facility:User reports an incident involving a tubing vent failure that resulted in a chemo spill.No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896571 ↗
• MalfunctionJun 15, 2026Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: SECONDARY SET HAD A FAULTY ROLLER CLAMP AND LOCK DOES NOT SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25500787 ↗
• MalfunctionMay 21, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE HOSPITAL IS EXPERIENCING ISSUES WITH THE B BRAUN SECONDARY IV ADMINISTRATION SETS, WHERE THE CAPS ARE POPPING OFF DURING CHEMOTHERAPY ADMINISTRATION, RESULTING IN CHEMO SPILLS.

  Patient problems: Chemical Exposure

  MAUDE report 25244128 ↗
• MalfunctionMay 14, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: RNS ARE PULLING THE VENT OUT OF TUBING CAUSING MEDICATIONS TO SPILL OUT. AT THE END OF A SECONDARY INFUSION, NURSES WILL FLIP OPEN THE VENT IN THE DRIP CHAMBER TO HELP PUSH THROUGH THE REMAINING FLUID. THIS IS WHEN THEY FEEL THE BAG HAS COLLAPSED AND CHEMO SPILLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179372 ↗
• MalfunctionMay 14, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: RNS ARE PULLING THE VENT OUT OF TUBING CAUSING MEDICATIONS TO SPILL OUT. AT THE END OF A SECONDARY INFUSION, NURSES WILL FLIP OPEN THE VENT IN THE DRIP CHAMBER TO HELP PUSH THROUGH THE REMAINING FLUID. THIS IS WHEN THEY FEEL THE BAG HAS COLLAPSED AND CHEMO SPILLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179369 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component; Infusion or Flow Problem; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: THE GAS VALVE FAILED, ALLOWING BUBBLES IN THE LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159326 ↗
• MalfunctionApr 2, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: AFTER OPENING THE VENT ON THE VINCRISTINE BAG, CHEMO WAS NOTED TO BE LEAKING FROM THE BAG. INITIALLY, THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED, AND THE SECONDARY LINE WAS CLAMPED. THE LEAK PERSISTED, AND IT WAS SUBSEQUENTLY DETERMINED THAT THE LEAK WAS ORIGINATING FROM THE VENT OF THE CHEMOTHERAPY BAG. THE BAG WAS IMMEDIATELY GRASPED, TURNED UPSIDE DOWN, AND REMOVED FROM THE Y-PORT OF THE PRIMARY LINE. THE IV PUMP WAS CHANGED AND NEW LINES PRIMED FOR THE PATIENT. A SPILL KIT WAS UTILIZED TO CLEAN CHEMOTHERAPY FROM THE FLOOR AND THE IV PUMP. THE FLOOR WAS THEN FURTHER CLEANED WITH SPA AND WATER AND THEN DISINFECTED WITH PURPLE WIPES. THE IV PUMP WAS COVERED WITH A YELLOW (CHEMO) BIOHAZARD BAG AND PLACED IN THE DIRTY UTILITY ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764876 ↗
• MalfunctionMar 18, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE VENT POPPED OUT OF DRIP CHAMBER CAUSING CHEMO SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634869 ↗
• MalfunctionFeb 16, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE ISSUE HAS HAPPENED TWICE WITH VINCRISTINE IN THE PAST FEW MONTHS IN PEDIATRICS. WE ADMINISTER THIS CHEMOTHERAPY VIA GRAVITY HANG. WHEN THE NURSES OPEN THE VENT, THE ENTIRE PLASTIC PIECE COMES OUT. IF THEY ARE HOLDING THE INFUSION UPRIGHT, IT LEADS TO A SPILL. NURSES HAVE BEEN INSTRUCTED TO OPEN THE VENT BEFORE HANGING THE BAG DUE TO AWARENESS OF THIS ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348645 ↗
• MalfunctionFeb 13, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: THE ISSUE HAS HAPPENED TWICE WITH VINCRISTINE IN THE PAST FEW MONTHS IN PEDIATRICS. WE ADMINISTER THIS CHEMOTHERAPY VIA GRAVITY HANG. WHEN THE NURSES OPEN THE VENT, THE ENTIRE PLASTIC PIECE COMES OUT. IF THEY ARE HOLDING THE INFUSION UPRIGHT, IT LEADS TO A SPILL. NURSES HAVE BEEN INSTRUCTED TO OPEN THE VENT BEFORE HANGING THE BAG DUE TO AWARENESS OF THIS ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332807 ↗
• MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY WHEN THE NURSE OPENED THE VALVE BELOW THE DRIP CHAMBER THE ENTIRE CLEAR PLASTIC PIECE FELL OFF. THIS PIECE CONTAINS A FILTER AND WITHOUT IT, IT OPENS THE LINE TO THE ENVIRONMENT MAKING IT NO LONGER A CLOSED/STERILE SYSTEM. IT COULD HAVE ALSO EXPOSED THE PATIENT AND NURSE TO CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526619 ↗
• MalfunctionNov 5, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DURING THERAPY WHEN THE NURSE OPENED THE VALVE BELOW THE DRIP CHAMBER THE ENTIRE CLEAR PLASTIC PIECE FELL OFF. THIS PIECE CONTAINS A FILTER AND WITHOUT IT, IT OPENS THE LINE TO THE ENVIRONMENT MAKING IT NO LONGER A CLOSED/STERILE SYSTEM. IT COULD HAVE ALSO EXPOSED THE PATIENT AND NURSE TO CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476263 ↗
• MalfunctionSep 11, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "AS THE NURSE WENT TO START CHEMOTHERAPY INFUSION OF DOXORUBICIN. MEDICATION WAS SPIKED AND WHEN HUNG ON THE IV POLES MEDICATION BEGAN SPILLING OUT OF A HOLE IN THE TUBING. MEDICATION WAS IMMEDIATELY TURNED UPSIDE DOWN TO STOP THE SPILL. MEDICATION WAS NOTED TO BE ON THE IV POLE, IV TUBING, FLOOR, AND PPT THAT WAS BEING WORN BY THE NURSE. IV TUBING WAS CHANGED AND IV POLE SWITCHED TO A CLEAN SET. PT WAS MOVED TO A DIFFERENT TREATMENT CHAIR AND SPILL AREA WAS CLEANED PER PROTOCOL.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025360 ↗
• MalfunctionAug 24, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT EXACTLY AS IT OCCURRED: THE NURSE WAS GOING TO PREPARE PRE-MEDS FOR A PATIENT. AN ADULT SECONDARY SET LUER LOCK WAS UNPACKAGED, AND THEN THE SPIKE CAP WAS REMOVED. REPORTEDLY, THE SPIKE WAS COVERED IN A BLACK RESIDUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881594 ↗
• MalfunctionMay 30, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SECONDARY CALCIUM GLUCONATE INFUSION "POURING IN" AT UNEXPECTEDLY FAST RATE - SUSPECTED BACKCHECK VALVE ISSUE. DETAILED INQUIRY DESCRIPTION: WHILE ON SITE FOR AN INTEGRATION GO-LIVE EVENT AT (B)(6) HOSPITAL, CTICU NURSE IN ROOM 434 REPORTEDLY PROGRAMMED NS AS A PRIMARY AND CALCIUM GLUCONATE AS A SECONDARY, AND THE NURSE STATED THAT CALCIUM GLUCONATE WAS "POURING IN" AT AN UNEXPECTEDLY FAST RATE WHEN STARTED ON PUMP 855807. THE NURSE OBSERVED THE SAME ISSUE WHEN ATTEMPTING TO DELIVER THE SAME INFUSION ON PUMP 855812. UPON INVESTIGATION, THE NURSE RESTARTED THE INFUSION TO DEMONSTRATE THE ISSUE, AND THE SECONDARY DRIP CHAMBER DISPLAYED NO ACTIVITY (NO DRIPS NOTED), BUT THE PRIMARY DRIP CHAMBER SHOWED UNEXPECTED ACTIVITY (DRIPS NOTED) DESPITE A NEARLY FULL BAG OF SECONDARY MEDICATION AND THE PRIMARY BAG PHYSICALLY LOWERED COMPARED TO THE SECONDARY BAG (GREEN HANGER IN USE TO ACCOMPLISH THE HEIGHT DIFFERENCE). SUSPECTING A TUBING PROBLEM, THE NURSE REPLACED THE PRIMARY BAG, PRIMARY TUBING, AND SECONDARY TUBING AND MANUALLY PROGRAMMED THE NS AND CALCIUM GLUCONATE ON A NEW PUMP (855828). THE CALCIUM GLUCONATE INFUSED AS A SECON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115497 ↗
• MalfunctionMay 9, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: SET LEAKED PRIOR TO ADMIN. DETAILED INQUIRY DESCRIPTION: TUBING HAD A CUT IN TUBING THAT LEAKED CHEMO. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993508 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "TODAY IN OUR CANCER CENTER IN ANTIOCH, KAISER, B-BRAUN TUBING BROKE, CHEMOTHERAPY (DOXORUBICIN, VESICANT) SPILLED ON THE FLOOR, AND A NURSE'S CHEMOTHERAPY GOWN. THIS INCIDENT AND MANY OTHERS HAVE OCCURRED WHILE THE NURSES WERE ADMINISTERING CHEMOTHERAPY. THE LOT NUMBER IS NOT AVAILABLE DUE TO THE CHEMOTHERAPY BEING MADE AND SPIKED (TUBING) VIA THE PHARMACY DEPARTMENT." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344267 ↗
• MalfunctionJan 3, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: UNINTENTIONAL DISCONNECTION OF 412160 FROM PORT ON PRIMARY LINE. DETAILED INQUIRY DESCRIPTION: "NURSE STOPPED CHEMO INFUSION DUE TO PATIENT REACTION AND REMOVED PRIMARY LINE FROM PORT. WHEN THIS WAS DONE THE CHEMO CONNECTOR POPPED OFF THE SECONDARY SET WHERE IT CONNECTS TO THE CLAVE. THE CLAMP WAS ALSO STILL OPEN CAUSING CHEMO TO DRIP ON THE FLOOR. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067021 ↗
• MalfunctionNov 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: BLACK STUFF ON SECONDARY SET SPIKE. RN OPENED BAG AND NOTICED BLACK STUFF ON SPIKE. TRIED TO WIPE OFF BUT IT DID NOT COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586556 ↗
• MalfunctionOct 9, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED, OUR HOSPITAL IS SEEING DEVICE ISSUES WHEN USING EITHER THE B. BRAUN INFUSOMAT SPACE PUMP IV SET (REF: (B)(4)) OR THE B. BRAUN SECONDARY IV SET (REF: (B)(4)). WE ARE SEEING THE MEDICATIONS EITHER BACKFLOW INTO THE PRIMARY LINE OR RAPIDLY INFUSE. WE BELIEVE THAT A CHECK VALVE IS NOT PERFORMING AS INTENDED IN CERTAIN LOTS OF THESE SETS. IN THIS INSTANCE: MEROPENEM ORDERED AT A RATE OF 500MG/100ML OVER 3 HOURS. 33.3/ML AN HOUR. HUNG AT ABOUT 4:20. ALREADY UNSTABLE PATIENT BEGAN TO DECOMPENSATE (INCREASED HR/ATRIAL FIBRILLATION), NURSING VERIFIED MEDICATIONS AND FOUND THAT MEROPENEM MEDICATION HAD BEEN FULLY ADMINISTERED. THE MEDICATION INFUSED RAPIDLY. B. BRAUN TUBING; REF: (B)(4), LOT: 0061929620, B. BRAUN SECONDARY TUBING; REF: (B)(4), LOT: 0061923959.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 20412226 ↗
• MalfunctionOct 9, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED, HOSPITAL IS SEEING DEVICE ISSUES WHEN USING EITHER THE B. BRAUN INFUSOMAT SPACE PUMP IV SET (REF: (B)(4)) OR THE B. BRAUN SECONDARY IV SET (REF: (B)(4)). WE ARE SEEING THE MEDICATIONS EITHER BACKFLOW INTO THE PRIMARY LINE OR RAPIDLY INFUSE. WE BELIEVE THAT A CHECK VALVE IS NOT PERFORMING AS INTENDED IN CERTAIN LOTS OF THESE SETS. IN THIS EVENT: 2G/50ML BAG MAGNESIUM SULFATE WAS BEING PREPARED AND SET UP IN IV PUMP. PRIMARY RN NOTICED THE RATE AT WHICH THE MAGNESIUM WAS DRIPPING IN CHAMBER WAS AT A VERY RAPID RATE, DESPITE BEING PROGRAMMED APPROPRIATELY IN BRAUN IV PUMP. PUMP WAS SET UP TO RUN AT 100ML/HR. PRIMARY RN CHANGED THE PUMP AND THE ISSUE DID NOT RESOLVE. RN THEN CHANGED THE SECONDARY TUBING AND MAGNESIUM BAG AND ISSUE STILL DID NOT RESOLVE. RN ALSO SET UP BASIC INFUSION RATE TO DRIP AT A VERY SLOW RATE TO EVALUATE IF DRIP RATE WOULD CHANGE. WAS SET UP 10ML/HR FOR 100ML BAG IN PUMP AND DRIP WAS STILL THE SAME RAPID RATE. BRAUN LOTS BEING USE WERE REF: (B)(4), LOT #: 0061929393 DATED 01/31/2029. SECONDARY IV TUBING WAS CHANGED TO A DIFFERENT LOT # AND THE ISSUE RESOLVED AND DRIP RATE IN CHAMBER WAS AT APPROPRIATE RATE AS PROGRAMMED IN PUMP. THIS LEAD TO A DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411678 ↗
• MalfunctionOct 9, 2024Leak/Splash; Free or Unrestricted Flow; Leak/Splash; Free or Unrestricted Flow

  AS REPORTED BY USER FACILITY, ADMINISTERING (B)(4) UNIT PRBC TO PATIENT WHEN TUBING STARTED LEAKING AT THE DISC ABOVE THE Y PORT. IT WAS UNABLE TO BE TIGHTENED OR ADJUSTED. DELAY IN TREATMENT AS A RESULT. OUR HOSPITAL IS SEEING DEVICE ISSUES WHEN USING EITHER THE B. BRAUN INFUSOMAT SPACE PUMP IV SET (B)(4) OR THE BBRAUN SECONDARY IV SET (B)(4)). WE ARE SEEING THE MEDICATIONS EITHER BACKFLOW INTO THE PRIMARY LINE OR RAPIDLY INFUSE. WE BELIEVE THAT A CHECK VALVE IS NOT PERFORMING AS INTENDED IN CERTAIN LOTS OF THESE SETS. REF REPORTS: MW5156432, MW5156433.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407669 ↗
• MalfunctionAug 13, 2024Reflux within Device; Free or Unrestricted Flow; Reflux within Device; Free or Unrestricted Flow

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION. MULTIPLE EVENTS OF SECONDARY SET BACKFLOWING INTO PRIMARY SETS AS REPORTED IN MEDWATCH MW5156413: DESCRIBE EVENT OR PROBLEM: OUR HOSPITAL IS SEEING DEVICE ISSUES WHEN USING EITHER THE BBRAUN INFUSOMAT SPACE PUMP IV SET (REF (B)(4) ) OR THE BBRAUN SECONDARY IV SET (REF (B)(4) ). WE ARE SEEING THE MEDICATIONS EITHER BACKFLOW INTO THE PRIMARY LINE OR RAPIDLY INFUSE. WE BELIEVE THAT A CHECK VALVE IS NOT PERFORMING AS INTENDED INCERTAIN LOTS OF THESE SETS. FOR THIS EVENT: IV TYLENOL HUNG ON SECONDARY INFUSED IN LESS THAN A MINUTE. ATTEMPTED TO HANG IV ZOSYN (WITH SAME LOT SECONDARY TUBING LOT NUMBER) ALSO STARTED RAPIDLY EMPTYING. BOTH SECONDARY TUBING WERE BBRAUN REF V1921, LOT 0061923959. PRIMARY TUBING REF (B)(4), LOT 0061929620. REHUNG SAME SECONDARY TUBING FOR ZOSYN WITH NEW PRIMARY TUBING SET AND DID NOT RAPIDLY INFUSE. REF REPORT: MW5156412.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976400 ↗
• MalfunctionJul 10, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: V1921 FLOWING TO FAST. DETAILED INQUIRY DESCRIPTION: V1921 FLOWING TO FAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709504 ↗
• MalfunctionJun 25, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: ZOSYN IVPB FREE-FLOW CONCERNS AT (B)(6) HOSPITAL. DETAILED INQUIRY DESCRIPTION: RECEIVED THE FOLLOWING EMAIL FROM (B)(6) ON 5/29/2024. "THERE WAS AN INCIDENT WITH BRAUN PUMP INFUSING ZOSYN LAST NIGHT ON 1 W AN INCIDENT REPORT WAS PLACED. DATE (B)(6) 2024 TIME 5:21 AM: RN STATES BRAUN INTEGRATION USED WAS IN THE ROOM WITH PT AND IVPB INFUSED FREELY. THIS IS DOCUMENTED ON INFUSION VERIFIER ON SCREEN SHOT RN ALSO STATED AFTER THIS OCCURRED THE PUMP STILL SAID ZOSYN HAD OVER 3 HOURS REMAINING TO INFUSE ON BRAUN PUMP LANDING SCREEN WHICH I ALSO SAW ON THE PUMP. THE PUMP AND TUBING IS NOW IN BIO MED: BME # S001182 BAR CODE 807421. LOT # PIGGY BACK TUBING 0061934189." CUSTOMER ISOLATED PUMP AND TUBING SAMPLES IN BIOMED. EPIC EHR SCREENSHOT (ATTACHED) DISPLAYS 0.99 ML VOLUME INFUSED BY PUMP FROM 05:21 TO 05:26.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606005 ↗