Alaris, SmartSite 2000ERecalls & reported problems

Summary

The FDA's MAUDE database contains 496 adverse event reports that list this exact device (DI 07613203011938), received between Sep 29, 2017 and Sep 13, 2026 — classified as 1 death, 3 injuries, 492 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (248 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 496 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747858 ↗
• MalfunctionSep 8, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676789 ↗
• MalfunctionSep 7, 2026Obstruction of Flow

  Patient problems: Insufficient Information

  MAUDE report 50654818 ↗
• MalfunctionSep 4, 2026Leak/Splash; Loose or Intermittent Connection

  No additional information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612418 ↗
• MalfunctionAug 31, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520504 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520502 ↗
• MalfunctionAug 28, 2026Complete Blockage

  It was reported that BD smartsite needle free connector was occluded.The following information was received by the initial reporter with the following Verbatim.It was reported by the customer that unable to push the saline thru.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488630 ↗
• MalfunctionAug 26, 2026Connection Problem

  Patient problems: Insufficient Information

  MAUDE report 50454722 ↗
• MalfunctionJul 1, 2026Obstruction of Flow

  IT WAS REPORTED, MAXZERO, OCCLUSION. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: WHEN THIS PATIENT UNDERWENT AN IMPLANTED PORT INFUSION ON (B)(6) 2026, A TUBING FLUSH TO A NEEDLELESS CLOSED INFUSION CONNECTOR WAS FOUND TO BE POORLY INJECTED AND UNUSABLE, AND THE CATHETER WAS CLEARED AFTER THE REMOVAL OF THE CLOVERLEAF.

  Patient problems: Insufficient Information

  MAUDE report 25677975 ↗
• MalfunctionJun 7, 2026Obstruction of Flow

  IT WAS REPORTED, ALARIS SMARTSITE, OCCLUSION. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: THE PATIENT REQUIRED MULTIPLE INTRAVENOUS LINES, SO A THREE-WAY VALVE WAS USED TO CONNECT A NEEDLELESS INJECTION CAP. HOWEVER, AFTER CONNECTING THE SYSTEM, IT WAS FOUND THAT THERE WAS SIGNIFICANT RESISTANCE AND THE SOLUTION COULD NOT BE ADMINISTERED, SO THE NEEDLELESS INJECTION CAP WAS REPLACED WITH ONE FROM A DIFFERENT BRAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422435 ↗
• MalfunctionMay 26, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS HAPPENING IS THE NEEDLE-FREE VALVE WE USE TO PUT ON THE END OF OUR IVS IS ESSENTIALLY ALLOWING CONTRAST/SALINE/BLOOD TO LEAK BETWEEN IT AND THE IV. SOMETIMES THE IV WILL BLOW, SOMETIMES IT WON'T, SOMETIMES TECHS ARE RANDOMLY HEARING A POP SOUND WHEN FLUSHING SALINE THROUGH BY INJECTOR TO CHECK THE IV AND TWO INSTANCES A PATIENT HEARD IT TOO. THIS WAS ON THE SAME PATIENT, HAD AN IV STARTED IN IVR RN AREA, PATIENT REPORTED SHE HEARD A POP AND THEN THE SALINE WAS LEAKED OUT UNDER THE TEGADERM. SO ANOTHER IV WAS RESTARTED ON THE TABLE (THE VALVE WOULD HAVE COME FROM OVER HERE IN CT) AND WHILE IT APPEARED TO FLUSH, WHEN THE SCAN WAS DONE AND A TECH WENT BACK OUT TO TELL HER THEY WERE DONE, THE CONTRAST HAD LEAKED OUT ON THE PILLOWS AND ONTO HER SHIRT. SHE THEN STATED THAT SHE HEARD THE POP AGAIN WHEN THE INJECTION STARTED. I JUST GOT WORD THAT NLR MSC IS EXPERIENCING ISSUES WITH THEM AS WELL WITH REPORTS OF NOT BEING ABLE TO PULL BLOOD BACK FOR CREATININE. THEY EXCHANGE THE VALVE OUT WITH ANOTHER ONE, AND IT WILL WORK JUST FINE. WHEN TRYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292079 ↗
• MalfunctionMay 26, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS HAPPENING IS THE NEEDLE-FREE VALVE WE USE TO PUT ON THE END OF OUR IVS IS ESSENTIALLY ALLOWING CONTRAST/SALINE/BLOOD TO LEAK BETWEEN IT AND THE IV. SOMETIMES THE IV WILL BLOW, SOMETIMES IT WON'T, SOMETIMES TECHS ARE RANDOMLY HEARING A POP SOUND WHEN FLUSHING SALINE THROUGH BY INJECTOR TO CHECK THE IV AND TWO INSTANCES A PATIENT HEARD IT TOO. THIS WAS ON THE SAME PATIENT, HAD AN IV STARTED IN IVR RN AREA, PATIENT REPORTED SHE HEARD A POP AND THEN THE SALINE WAS LEAKED OUT UNDER THE TEGADERM. SO ANOTHER IV WAS RESTARTED ON THE TABLE (THE VALVE WOULD HAVE COME FROM OVER HERE IN CT) AND WHILE IT APPEARED TO FLUSH, WHEN THE SCAN WAS DONE AND A TECH WENT BACK OUT TO TELL HER THEY WERE DONE, THE CONTRAST HAD LEAKED OUT ON THE PILLOWS AND ONTO HER SHIRT. SHE THEN STATED THAT SHE HEARD THE POP AGAIN WHEN THE INJECTION STARTED. I JUST GOT WORD THAT NLR MSC IS EXPERIENCING ISSUES WITH THEM AS WELL WITH REPORTS OF NOT BEING ABLE TO PULL BLOOD BACK FOR CREATININE. THEY EXCHANGE THE VALVE OUT WITH ANOTHER ONE, AND IT WILL WORK JUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291427 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS HAPPENING IS THE NEEDLE-FREE VALVE WE USE TO PUT ON THE END OF OUR IVS IS ESSENTIALLY ALLOWING CONTRAST/SALINE/BLOOD TO LEAK BETWEEN IT AND THE IV. SOMETIMES THE IV WILL BLOW, SOMETIMES IT WON'T, SOMETIMES TECHS ARE RANDOMLY HEARING A POP SOUND WHEN FLUSHING SALINE THROUGH BY INJECTOR TO CHECK THE IV AND TWO INSTANCES A PATIENT HEARD IT TOO. THIS WAS ON THE SAME PATIENT, HAD AN IV STARTED IN IVR RN AREA, PATIENT REPORTED SHE HEARD A POP AND THEN THE SALINE WAS LEAKED OUT UNDER THE TEGADERM. SO ANOTHER IV WAS RESTARTED ON THE TABLE (THE VALVE WOULD HAVE COME FROM OVER HERE IN CT) AND WHILE IT APPEARED TO FLUSH, WHEN THE SCAN WAS DONE AND A TECH WENT BACK OUT TO TELL HER THEY WERE DONE, THE CONTRAST HAD LEAKED OUT ON THE PILLOWS AND ONTO HER SHIRT. SHE THEN STATED THAT SHE HEARD THE POP AGAIN WHEN THE INJECTION STARTED. I JUST GOT WORD THAT NLR MSC IS EXPERIENCING ISSUES WITH THEM AS WELL WITH REPORTS OF NOT BEING ABLE TO PULL BLOOD BACK FOR CREATININE. THEY EXCHANGE THE VALVE OUT WITH ANOTHER ONE, AND IT WILL WORK JUST FINE. WHEN TRYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291337 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS HAPPENING IS THE NEEDLE-FREE VALVE WE USE TO PUT ON THE END OF OUR IVS IS ESSENTIALLY ALLOWING CONTRAST/SALINE/BLOOD TO LEAK BETWEEN IT AND THE IV. SOMETIMES THE IV WILL BLOW, SOMETIMES IT WON'T, SOMETIMES TECHS ARE RANDOMLY HEARING A POP SOUND WHEN FLUSHING SALINE THROUGH BY INJECTOR TO CHECK THE IV AND TWO INSTANCES A PATIENT HEARD IT TOO. THIS WAS ON THE SAME PATIENT, HAD AN IV STARTED IN IVR RN AREA, PATIENT REPORTED SHE HEARD A POP AND THEN THE SALINE WAS LEAKED OUT UNDER THE TEGADERM. SO ANOTHER IV WAS RESTARTED ON THE TABLE (THE VALVE WOULD HAVE COME FROM OVER HERE IN CT) AND WHILE IT APPEARED TO FLUSH, WHEN THE SCAN WAS DONE AND A TECH WENT BACK OUT TO TELL HER THEY WERE DONE, THE CONTRAST HAD LEAKED OUT ON THE PILLOWS AND ONTO HER SHIRT. SHE THEN STATED THAT SHE HEARD THE POP AGAIN WHEN THE INJECTION STARTED. I JUST GOT WORD THAT NLR MSC IS EXPERIENCING ISSUES WITH THEM AS WELL WITH REPORTS OF NOT BEING ABLE TO PULL BLOOD BACK FOR CREATININE. THEY EXCHANGE THE VALVE OUT WITH ANOTHER ONE, AND IT WILL WORK JUST FINE. WHEN TRYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291313 ↗
• MalfunctionMay 26, 2026Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE HAD AIR BUBBLES / AIR IN LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS HAPPENING IS THE NEEDLE-FREE VALVE WE USE TO PUT ON THE END OF OUR IVS IS ESSENTIALLY ALLOWING CONTRAST/SALINE/BLOOD TO LEAK BETWEEN IT AND THE IV. SOMETIMES THE IV WILL BLOW, SOMETIMES IT WON'T, SOMETIMES TECHS ARE RANDOMLY HEARING A POP SOUND WHEN FLUSHING SALINE THROUGH BY INJECTOR TO CHECK THE IV AND TWO INSTANCES A PATIENT HEARD IT TOO. THIS WAS ON THE SAME PATIENT, HAD AN IV STARTED IN IVR RN AREA, PATIENT REPORTED SHE HEARD A POP AND THEN THE SALINE WAS LEAKED OUT UNDER THE TEGADERM. SO ANOTHER IV WAS RESTARTED ON THE TABLE (THE VALVE WOULD HAVE COME FROM OVER HERE IN CT) AND WHILE IT APPEARED TO FLUSH, WHEN THE SCAN WAS DONE AND A TECH WENT BACK OUT TO TELL HER THEY WERE DONE, THE CONTRAST HAD LEAKED OUT ON THE PILLOWS AND ONTO HER SHIRT. SHE THEN STATED THAT SHE HEARD THE POP AGAIN WHEN THE INJECTION STARTED. I JUST GOT WORD THAT NLR MSC IS EXPERIENCING ISSUES WITH THEM AS WELL WITH REPORTS OF NOT BEING ABLE TO PULL BLOOD BACK FOR CREATININE. THEY EXCHANGE THE VALVE OUT WITH ANOTHER ONE, AND IT WILL WORK JUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291156 ↗
• MalfunctionMay 26, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHAT IS HAPPENING IS THE NEEDLE-FREE VALVE WE USE TO PUT ON THE END OF OUR IVS IS ESSENTIALLY ALLOWING CONTRAST/SALINE/BLOOD TO LEAK BETWEEN IT AND THE IV. SOMETIMES THE IV WILL BLOW, SOMETIMES IT WON'T, SOMETIMES TECHS ARE RANDOMLY HEARING A POP SOUND WHEN FLUSHING SALINE THROUGH BY INJECTOR TO CHECK THE IV AND TWO INSTANCES A PATIENT HEARD IT TOO. THIS WAS ON THE SAME PATIENT, HAD AN IV STARTED IN IVR RN AREA, PATIENT REPORTED SHE HEARD A POP AND THEN THE SALINE WAS LEAKED OUT UNDER THE TEGADERM. SO ANOTHER IV WAS RESTARTED ON THE TABLE (THE VALVE WOULD HAVE COME FROM OVER HERE IN CT) AND WHILE IT APPEARED TO FLUSH, WHEN THE SCAN WAS DONE AND A TECH WENT BACK OUT TO TELL HER THEY WERE DONE, THE CONTRAST HAD LEAKED OUT ON THE PILLOWS AND ONTO HER SHIRT. SHE THEN STATED THAT SHE HEARD THE POP AGAIN WHEN THE INJECTION STARTED. I JUST GOT WORD THAT NLR MSC IS EXPERIENCING ISSUES WITH THEM AS WELL WITH REPORTS OF NOT BEING ABLE TO PULL BLOOD BACK FOR CREATININE. THEY EXCHANGE THE VALVE OUT WITH ANOTHER ONE, AND IT WILL WORK JUST FINE. WHEN TRYING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291151 ↗
• MalfunctionMay 25, 2026Connection Problem

  IT IS REPORTED, DURING THE CONNECTION PROCESS, THE BARREL IMMEDIATELY RETRACTED, PREVENTING THE MEDICATION FROM BEING INJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272038 ↗
• MalfunctionMay 14, 2026Blocked Connection

  IT IS REPORTED, LL VLV ADPT(STAND ALONE), THE INFUSION FLOW WAS OBSTRUCTED. UPON DISCONNECTING THE INFUSION SET, IT WAS DISCOVERED THAT THE TUBING OF THE INFUSION CONNECTOR WAS BLOCKED. USE WAS IMMEDIATELY DISCONTINUED, AND A NEW INFUSION CONNECTOR WAS INSTALLED.

  Patient problems: Insufficient Information

  MAUDE report 25172971 ↗
• MalfunctionMay 5, 2026Obstruction of Flow

  IT IS REPORTED, ALARIS SMARTSITE, FLUID DOES NOT FLOW, WHICH AFFECTS PATIENT TREATMENT AND RESULTS IN A WASTE OF MEDICATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086650 ↗
• MalfunctionApr 27, 2026Obstruction of Flow

  IT IS REPORTED, THE INTRAVENOUS INFUSION LINK POSITIVE PRESSURE CONNECTOR SET HAD BLOCKAGE. ADDITIONAL INFORMATION: INITIAL CONNECTION WAS NOT SMOOTH; BLOCKAGE. PLEASE CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? NONE; COMMUNICATED WITH THE PATIENT; PRE-FILLED THE CONNECTOR IN ADVANCE PLEASE CONFIRM IF THE CONNECTING PRODUCT HAS A LUER SLIP OR LUER LOCK CONNECTION? LUER-LOCK CONNECTOR PLEASE CONFIRM WHETHER THE FLOW WAS COMPLETELY OR PARTIALLY BLOCKED? PARTIAL BLOCKAGE PLEASE CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED DURING THE EVENT? INFUSION HAS NOT YET STARTED PLEASE CONFIRM IS THERE ANY PATIENT HARM? NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004842 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: A PATIENT UNDERWENT CATHETER-BASED TREATMENT AT A (B)(6) ONCOLOGY CENTER AND WAS DISCHARGED HOME WITH THE CATHETER IN PLACE. WHILE AT HOME, THE CATHETER CONNECTOR FRACTURED; UPON PRESENTING TO A LOCAL FACILITY FOR REPLACEMENT, THE STAFF THERE STATED THEY WERE UNABLE TO HANDLE THE PROCEDURE. CONSEQUENTLY, THE HEAD NURSE EXPRESSED CONCERN REGARDING THE PATIENT'S RISK OF INFECTION. THIS SPECIFIC DEPARTMENT WITHIN THE HOSPITAL HAS RECENTLY EXPERIENCED MULTIPLE INCIDENTS INVOLVING THE FRACTURE OF "2000E CHINA" CATHETERS, WITH THE FRACTURE SITES BEING NEARLY IDENTICAL IN ALMOST EVERY CASE. BASED ON THE INFORMATION GATHERED TO DATE: 1. FRACTURES HAVE OCCURRED IN BOTH COMPETITOR PRODUCTS AND BD'S OWN PICC CATHETERS. THERE IS NO DISCERNIBLE CONSISTENCY ACROSS THE SPECIFIC BATCHES OF "2000E CHINA" CATHETERS INVOLVED IN THESE FRACTURES. 2. NO CORRELATION HAS YET BEEN ESTABLISHED BETWEEN THE DURATION OF CATHETER INDWELLING AND THE OCCURRENCE OF FRACTURES; IN OTHER WORDS, FRACTURES HAVE OCCURRED REGARDLESS OF WHETHER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972272 ↗
• MalfunctionApr 16, 2026Obstruction of Flow

  IT IS REPORTED, THE FLUID FAILED TO DRIP. DESPITE REPEATED ADJUSTMENTS, THE DEVICE COULD NOT BE MADE TO FUNCTION PROPERLY, RESULTING IN A DELAY IN THE PATIENT¿S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905184 ↗
• MalfunctionApr 14, 2026Obstruction of Flow

  IT IS REPORTED, THE NURSE CONNECTED THE TRANSFUSION SET TO THE POSITIVE PRESSURE PORT, BUT NO FLUID FLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875422 ↗
• MalfunctionApr 13, 2026Obstruction of Flow

  IT IS REPORTED, AFTER CONNECTING THE INFUSION SET TO THE NEEDLELESS INJECTION CAP, THE FLUID FAILED TO DRIP. ADDITIONAL INFORMATION: THE NURSE REPLACED THE CONNECTOR IN TIME AFTER FINDING THAT IT WAS NOT DRIPPING, AND IT DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853841 ↗
• MalfunctionApr 6, 2026Obstruction of Flow

  IT IS REPORTED, AFTER CONNECTING THE INFUSION SET TO THE NEEDLE FREE SEALED INFUSION CONNECTOR, THE FLUID FAILED TO FLOW SMOOTHLY. NO PATIENT HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792949 ↗