Alaris, SmartSite 20127ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, 1.2 Micron Low Protein Binding Filter, Needle-Free Valve 43 cm (18 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD Alaris SmartSite extension set, short IV tubing with a filter and needle-free valve used to give medicines and nutrition. The 54 reports mostly describe the line blocking so fluid stops flowing, plus leaking or splashing at the tubing, filter, or connections, and cracking or breaking where tubing meets the filter. No deaths and no injuries are reported. There are no recalls naming 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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07613203019248), received between Oct 15, 2018 and May 14, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (20 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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage20
- Leak/Splash11
- Fluid/Blood Leak7
- Break4
- Crack4
- Defective Component2
- Failure to Prime2
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- No Consequences Or Impact To Patient5
- No Information2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHILE DOING MY SAFETY CHECKS BEFORE STARTING CARES, THEY NOTICED FLUID ON THE FLOOR UNDERNEATH THE BED, AND IT WAS VERY STICKY LIKE TPN. THEY SAW IT DRIPPING FROM THE END OF THE BED. AFTER TRACING MY LINES, THEY FOUND DROPS ON THE IV TUBING AND AROUND THE JUNCTION WHERE THE MED PORT ON THE IV PUMP INFUSION SET IS LOCATED. THEY SHOWED MY ACTION RN (B)(6) AND NOTIFIED THE NNP (B)(6). GRABBED A BLOOD GLUCOSE WHICH WAS 90 AND THE NNP ORDERED NEW FLUIDS TO HANG. THEY PLACED A STICKER WHERE THEY NOTICED THE LEAKING OCCURRING ON TO THE TUBING EXTENSION SET ITSELF, PLACED IT ALL IN A BAG AND PUT IT IN OUR MANAGER'S BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25167023 ↗MalfunctionMay 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE PIV TPN TUBING WAS LEAKING FROM THE ACCESS PORT/Y-IN PORT CLOSEST TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086184 ↗MalfunctionFeb 20, 2026Separation Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT BREAKAGE WHERE TUBING CONNECTS TO THE FILTER
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24408056 ↗MalfunctionFeb 2, 2026Air/Gas in Device
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24241161 ↗MalfunctionJan 26, 2026Separation Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184162 ↗MalfunctionNov 3, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE FILTER IS GETTING OCCLUDED 90% AT THE TAIL END OF ADMINISTERING MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449062 ↗MalfunctionNov 3, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE FILTER IS GETTING OCCLUDED 90% AT THE TAIL END OF ADMINISTERING MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23448699 ↗MalfunctionApr 16, 2025Crack; Crack
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT LIPIDS NOTED TO BE LEAKING AT THE FILTER SITE OF THE FILTER TUBING. POSSIBLE CRACK TO THE TUBING, DIFFICULT TO VISUALIZE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 25-03-2025. ANY SAMPLE AVAILABLE FOR INVESTIGATION? YES. WAS THIS IS A CHEMO DRUG? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21849358 ↗MalfunctionMar 25, 2025Break; Break
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: LUER LOCK CONNECTOR PIECE AT END OF IV TUBING FOR PRE-STRUNG TPN SENT UP FROM PHARMACY BROKEN OFF. TPN BAG STRUNG WITH NEW FILTER TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21694278 ↗MalfunctionOct 30, 2024Crack; Crack
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT DURING TPN/LIPID LINE CHANGE, LIPID FILTER COULD NOT BE PRIMED. FILTER DISCONNECTED FROM ALARIS FLUID TUBING AND ATTEMPTED TO FLUSH WITH NS FLUSH- STILL UNABLE TO PRIME FILTER. FILTER ATTEMPTED TO BE REMOVED FROM "QUAD FUSE" AND END OF FILTER TUBING WAS CRACKED AND STUCK TO "QUAD FUSE." "QUAD FUSE" HAD TO BE REMOVED FROM ENTIRE LINE SET UP & REPLACED. FOUND BLUE FILTER HOLE TO NOT BE MOLDED ALL THE WAY THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571060 ↗MalfunctionOct 2, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAVE HAD SEVERAL REPORTS OF LIPIDS CLOGGING THE FILTER THEN ALARMING HIGH PRESSURE. NURSING IS ABLE TO FLUSH .9 THROUGH THE SYSTEM BUT LIPIDS STOP RUNNING. IN ONE EVENT THE LIPIDS ACTUALLY SOLIDIFIED IN THE TUBING, AND THEY WERE UNABLE TO FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20351609 ↗MalfunctionSep 16, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: FILTER WAS BEING USED TO PRIME WITH LIPIDS BUT AFTER PASSING THROUGH THE FILTER, LIPIDS WOULD NO LONGER PRIME THROUGH REMAINING END OF TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20233561 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM; RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE IV TUBING WAS BROKEN OFF AT THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20082151 ↗MalfunctionAug 23, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MATERIAL #: 20127E. BATCH #: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT LIPIDS WOULD NOT RUN THROUGH LINE. RN CHECK TO MAKE SURE ALL CLAMPS WERE UNDONE, AND FLUIDS WERE STILL NOT RUNNING THROUGH TUBING. FOUND BLUE PLASTIC BARRIER IN TUBE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE: PRIMARY RN ATTEMPTED TO RUN FLUID THROUGH IV TUBING FOR LIPIDS. LIPIDS WOULD NOT RUN THROUGH LINE. RN CHECK TO MAKE SURE ALL CLAMPS WERE UNDONE, AND FLUIDS WERE STILL NOT RUNNING THROUGH TUBING. FOUND BLUE PLASTIC BARRIER IN TUBE. LOOKS LIKE A MANUFACTURING ERROR. PRODUCT CODE: 20127E.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20045220 ↗MalfunctionMay 28, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19412396 ↗MalfunctionApr 17, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PATIENT IS GETTING LIPID NUTRITION VIA PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, AND LINES WERE CHANGED ON DAY SHIFT. THROUGHOUT THE NIGHT, THE PUMP WOULD INTERMITTENTLY ALARM OCCLUDED. EVENTUALLY FOUND THE LIPID FILTER TUBING WAS CLOGGED AND NOT FULLY RUNNING THE LIPIDS PROPERLY WHICH COULD CAUSE PATIENT TO NOT GET THE CORRECT NUTRITION ORDERED. BACKGROUND: PATIENT REQUIRES IV NUTRITION VIA HER PICC LINE DUE TO DIAGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19128794 ↗MalfunctionApr 17, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127837 ↗MalfunctionApr 16, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19119007 ↗MalfunctionApr 16, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: LIPIDS (IN BAG) KEPT ALARMING OCCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116964 ↗MalfunctionMar 28, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: DESCRIBE THE EVENT OR PROBLEM: LIPID FILTER TUBING SNAPPED, BROKE AFTER LINE CHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001373 ↗MalfunctionMar 11, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: LIPID FILTER OCCLUDED, REMOVED FILTER AND PUMP PRESSURE RETURNED TO NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882067 ↗MalfunctionFeb 28, 2024Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 20127E BATCH#: 23129307 IT WAS REPORTED BY THE CUSTOMER IV TUBING SCREW CAP CAME OFF THE LINE OF LIPID TUBING WAS THEN CONTAMINATED AND NO LONGER ABLE TO BE CONNECTED RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. IV TUBING SCREW CAP CAME OFF THE LINE OF LIPID TUBING WAS THEN CONTAMINATED AND NO LONGER ABLE TO BE CONNECTED COMMENTS ON 12/02/2024 1. PLEASE CONFIRM THAT BATCH NUMBER. (10)23129307 2. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? (B)(6). 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? UNKNOWN 4. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO 5. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PLEASE INCLUDE TREATMENT/INTERVENTION PROVIDED AND THE OUTCOME. NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18803515 ↗MalfunctionFeb 14, 2024Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: LIPID FILTER CAUSING HIGH PRESSURE ON PICC LINE. LIPIDS UNABLE TO INFUSE D/T HIGH PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18704566 ↗MalfunctionJan 30, 2024Partial Blockage; Partial Blockage
HOLD FOR RW 2.5 MATERIAL#: 20127E. LOT#: 23099460. IT WAS REPORTED BY THE CUSTOMER REPORTED THAT TPN AND SMOF LIPIDS HAS BEEN INFUSING ALL NIGHT THE LINE WAS CHECKED FOR KINKS, BUBBLES, AND IF IT WAS CLAMPED BECAUSE THE PUMP KEPT READING HIGH PRESSURE AND WOULD ONLY STOP ALARMING IF THE PRESSURE SETTING ON THE PUMP WAS TURNED UP. NO PATIENT HARM. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. TPN AND SMOF LIPIDS HAS BEEN INFUSING ALL NIGHT UNTIL ABOUT 0530 ON 01/04/2023. THE LINE WAS CHECKED FOR KINKS, BUBBLES, AND IF IT WAS CLAMPED BECAUSE THE PUMP KEPT READING HIGH PRESSURE AND WOULD ONLY STOP ALARMING IF THE PRESSURE SETTING ON THE PUMP WAS TURNED UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607875 ↗MalfunctionJan 30, 2024Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607713 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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