Alaris, SmartSite 30204ERecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10885403235177), received between Sep 11, 2019 and Sep 15, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777704 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777703 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777701 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777700 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777699 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777697 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777696 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777695 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777694 ↗
• MalfunctionFeb 11, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356766 ↗
• MalfunctionApr 24, 2023Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED WHILE USING BD SMALL BORE J-LOOP EXTENSION SET BACKFLOW AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE J-LOOP IS LEAKING FROM THE SITE WHERE THE TUBING CONNECTS INTO THE END OF THE TUBING. THEY ALSO STATED BLOOD WAS BACKING UP INTO THE TUBING AND THE J-LOOP NEEDED TO BE CHANGED. VERBATIM: J-LOOP IS LEAKING FROM THE SITE WHERE THE TUBING CONNECTS INTO THE END OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802283 ↗
• MalfunctionMar 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ER AND CT HAVE NOTED AN OCCURRENCE OF TUBING LEAKING /SPLIT AFTER PATIENT HAD HIGH PRESSURE INJECTION THRU THE TUBING: 30204E EXTENSION TUBING IS SPLIT/LEAKING FROM THE FLEXIBLE PLASTIC TUBING CLOSEST TO PATIENT END. CT TECH HAVE HAD TO CHANGE OVER THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592940 ↗
• MalfunctionMar 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ER AND CT HAVE NOTED AN OCCURRENCE OF TUBING LEAKING /SPLIT AFTER PATIENT HAD HIGH PRESSURE INJECTION THRU THE TUBING: 30204E EXTENSION TUBING IS SPLIT/LEAKING FROM THE FLEXIBLE PLASTIC TUBING CLOSEST TO PATIENT END. CT TECH HAVE HAD TO CHANGE OVER THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592720 ↗
• MalfunctionFeb 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS FOUND TO BE DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOLORATION OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402153 ↗
• MalfunctionFeb 10, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET WAS FOUND DISCOLORED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN TAKING DEVICES OUT OF THE BOX THE CONNECTOR PIECES WERE FOUND TO BE TWO DIFFERENT COLORS - ONE CLEAR ONE AMBER. UNCERTAIN IF THE DEVICE(S) IS/ARE USABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16345565 ↗
• MalfunctionFeb 4, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING ALARIS SMARTSITE EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH/LOT #: 21039703. MAT# 30204E. LEAKING BLOOD AT THE CONNECTION OF EXTENSION SET TO HUB OF NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13457343 ↗
• MalfunctionDec 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD SMARTSITE¿ EXTENSION SETS, AN ADDITIONAL OPEN PORT WAS OBSERVED CONNECTED TO THE INFLOW AND LACKED THE ABILITY TO CLOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THE SMARTSITE SET HAD AN EXTRA OPEN PORT ON DEVICE. VERBATIM: OUR ED FOUND ONE OF CARDINAL # AL30204E SMARTSITE¿ EXTENSION SET, SLIDE CLAMP(S), 1 SMARTSITE¿ NEEDLE-FREE VALVE(S) 4" FROM SPIN MALE LUER LOCK THAT HAD BEEN MADE WITH AN EXTRA OPEN PORT. IT IS DIRECTLY CONNECTED TO THE INFLOW WITH NOTHING TO CLOSE IT OFF. OUR ED DIRECTOR AND CHARGE NURSE TESTED THIS AND SAID IT CAN BE FATAL SINCE NOTHING STOPS AIR FROM ENTERING THE OPEN PORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047657 ↗
• MalfunctionNov 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET TUBING WAS CRACKED AND LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER PRESSING RUN PROCEDURE "NO REPLACEMENT FLUID DETECTED" ALARMED AND IT WAS NOTED THAT BLOOD WAS LEAKING FROM THE DRAW LINE LINES WERE CLAMPED AND IT WAS FOUND THAT THE CAUSE WAS THE EXTENSION TUBING WAS DEFECTIVE/CRACKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781794 ↗
• MalfunctionMar 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EXT SET W/VLV PORT & LL SEPARATED AT THE TIP CONNECTED TO THE PATIENTS CATHETER AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN ISSUE WITH ONE OF OUR EXTENSION SETS, USED FOR STEM CELL COLLECTION, AND RIGHT AT THE TIP IT IS COMPLETELY SEPARATED FROM WHERE IT IS SUPPOSED TO BE SEALED AND BLOOD IS LEAKING FROM THE TIP OF IT. IT¿S COMING FROM THE END THAT SCREWS ONTO THE PATIENT¿S CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529964 ↗
• MalfunctionJul 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET W/VLV PORT & LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 30204E; BATCH #: 20026167. IT WAS REPORTED THERE WAS A LEAKAGE. NO PATIENT OUTCOMES. LEAKING WAS DETECTED PRIOR TO ATTACHING TUBING TO PATIENT(S) AND CHANGED TO NON-LEAKING. THE COUPLE THAT WERE NOT DETECTED PRIOR TO USING ON PATIENT WERE NOT A PROBLEM BECAUSE ONCE IT WAS ATTACHED TO THE IV CATHETER IT WAS OPENED UP AND FLOWED AS IT SHOULD. THE LEAKING WAS WHEN TRYING TO CLAMP OFF THE EXTENSION TUBING. NO PATIENT ISSUES. PER OUR RN STAFF.

  Patient problems: No Patient Involvement

  MAUDE report 10217971 ↗
• MalfunctionJun 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EXT SET W/VLV PORT & LL CLAMP DID NOT OCCLUDE THE TUBE AND ALLOWED DRIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING AN ISSUE WITH 30204E SET IV EXTENSION 8IN 1-PORT WERE THE CLAMP IS NOT OCCLUDING THE TUBE AND ALLOWED DRIPPING. IT¿S UNCLEAR TO US IF THIS IS LOT NUMBER BASED OR AN ISSUE WITH THE PRODUCT AS A WHOLE.

  Patient problems: No Patient Involvement

  MAUDE report 10200871 ↗
• MalfunctionSep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A CT CONTRAST POWER INJECTION OF THE PATIENT'S ABDOMEN AND PELVIS, THE EXTENSION TUBING RUPTURED AND LEAKED. PRIOR TO THE CT, AN ULTRASOUND-GUIDED IV WAS PLACED IN RIGHT UPPER ARM. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8997655 ↗