Alaris, SmartSite 20029ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing, 0.2 Micron Low Protein Binding Filter, Needle-Free Valve 25 cm (10 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Alaris SmartSite extension set is a short length of IV tubing with a fine filter and a needle-free valve, used to connect to catheters and administer infusions such as TPN and medication. The 35 reports mostly describe fluid or blood leaking from the filter and tubing connections, sometimes a slow ooze, along with leaks or splashes, complete blockage that stopped critical medication from flowing, and a couple of cracks. Reports mention 3 injuries and no deaths. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10885403234866), received between Sep 4, 2018 and Sep 29, 2026 — classified as 3 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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
- Fluid/Blood Leak22
- Leak/Splash9
- Complete Blockage4
- Crack2
- Component Missing1
- Device Contamination with Chemical or Other Material1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient19
- No Clinical Signs, Symptoms or Conditions13
- Low Oxygen Saturation2
- No Patient Involvement2
- No Known Impact Or Consequence To Patient1
- Therapeutic Response, Decreased1
- Urinary Retention1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938130 ↗MalfunctionJun 11, 2025Component Missing; Component Missing
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185686 ↗MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD 10 INCH EXT W/ 0.2 PED & VLV PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A TPN TUBING NUMBER (B)(4) LOT NUMBER H37020029E1A LEAKING AT THE FILTER. (B)(6) 2024. 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. (B)(6) 2024. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO HARM EVIDENT, PHYSICAL OR OTHERWISE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410544 ↗MalfunctionAug 29, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: REPORTED ISSUE: WE ARE EXPERIENCING LEAKING ISSUES WITH IME20029E AND IT IS CREATING AN INFECTION RISK IN THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17647464 ↗MalfunctionAug 9, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS WERE NOT ABLE TO PRIME AND WERE LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WE ARE HAVING ISSUES WITH PART NUMBER 20029E, THE MICRON FILTER IS LEAKING AND THIS A HUGE SAFETY CONCERN BECAUSE A CRITICAL MED WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17490423 ↗MalfunctionJun 29, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ SMARTSITE¿ EXTENSION SET THE DEVICE ALARMED FOR OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT DURING THE LAST 6 MLS OF KANUMA INFUSING TO PATIENT, THE PUMP BEGAN BEEPING FOR OCCLUSION AT PATIENT SIDE. CONFIRMED PATENCY OF PORT A CATH BY ASPIRATION AND FLUSH. THEN ATTEMPTED TO FLUSH DISTAL TO SMALLBORE TUBING 0.2 MICRON LOW PROTEIN BINDING FLITER NEEDLE-FREE VALVE. DETERMINED OCCLUSION WAS AT THE FILTER. REMOVED FILTER TUBING AND REPLACED. INFUSION THEN COMPLETED WITHOUT FURTHER OCCLUSION. FAULTY TUBING SAMPLE SAVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17234674 ↗MalfunctionJun 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET HAD A LEAK. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM : COMPLAINT RECEIVED VIA EMAIL. EMAIL ATTACHED. CLINICIANS SAID THEY EXPERIENCE LEAKING AT THE CONNECTION OF FILTER EXTENSION TUBING REF# (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221587 ↗MalfunctionMay 18, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT APPROXIMATELY 10 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED AT THE EDGE OF THE FILTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE DB MAXZERO (MZ9270) MICROBORE TRI-FUSE EXTENSION SET 3 IV, FILTER SET. APPROX 10 SETS SO FAR HAVE BEEN FOUND LEAKING. THESE SETS ARE LEAKING AT THE FILTER, IT APPEARS TO BE A SLOW OOZING LEAK. NOT THE HUBS BUT AT THE FILTER. WE JUST HAD ANOTHER TRIPLE CONNECTOR START LEAKING ON A MICRO PREEMIE (1200 GRAMS). THIS IS A HUGE ISSUE AS OUR BABIES ARE NOT ONLY MISSING OUT ON NUTRITION, THIS GREATLY INCREASES THE RISK FOR INFECTION IN THESE IMMUNE COMPROMISED INFANTS. IT IS NOT CLOGGING; THE AREA IS LEAKING AT THE EDGE OF THE FILTER. THE TRI CONNECTORS ARE CHANGED DAILY. SEEMS TO BE HAPPENING SOON AFTER THE TPN CHANGE.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16959333 ↗MalfunctionMay 8, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REF20029E DID NOT ALLOW MANNITOL INFUSION TO FLOW THROUGH MICRON FILTER CAUSING A DELAY IN MEDICATION ADMINISTRATION ON A 2ND CRITICAL PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16892629 ↗MalfunctionMay 5, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DID NOT ALLOW MANNITOL INFUSION TO FLOW THROUGH MICRON FILTER CAUSING A DELAY IN MEDICATION ADMINISTRATION ON A CRITICAL PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16882166 ↗MalfunctionMar 24, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LEAKED AT THE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IMMEDIATELY AFTER HOOKING LINES UP TO PICC LINE NOTICED LEAKING AT THE CONNECTION OF THE 0.2 MICRON FILTER AND THE ANTI-SIPHON VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16614248 ↗MalfunctionOct 22, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV MED LINE TUBING AND MED LINE EXTENSION SET WITH FILTER LEAKING AT SITE OF CONNECTION FROM TUBING TO FILTER EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12684907 ↗MalfunctionJun 8, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE "FILTER DAME" CAME APART FROM THE 10 INCH EXT W/ 0.2 PED & VLV PORT EXTENSION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FILTER DAME APART FROM THE TUBING EXTENSION SET"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11957375 ↗MalfunctionFeb 2, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE 10 INCH EXT W/ 0.2 PED & VLV PORT WAS OCCLUDED DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A BD SMARTSITE EXTENSION SET THAT OCCLUDED WITH INFUSION."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11270426 ↗MalfunctionSep 29, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 6 10 INCH EXT W/ 0.2 PED & VLV PORTS EXPERIENCED LEAKAGE, COMPONENT SEPARATION, AND FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD 5 OF THE 0.2 MICRON FILTERS #20029E.THAT HAVE EITHER STARTED TURNING COLORS WITHIN THE FILTER OR CRACKED AND LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10602948 ↗MalfunctionSep 29, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 6 10 INCH EXT W / 0.2 PED & VLV PORT EXPERIENCED DAMAGE / DEFORMATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD 5 OF THE 0.2 MICRON FILTERS#: 20029E. THAT HAVE EITHER STARTED TURNING COLORS WITHIN THE FILTER OR CRACKED AND LEAKING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10601914 ↗MalfunctionMar 13, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE IV TUBING SET LEAKED DURING AN INFUSION OF TPN ON A PREMATURE BABY. FILTER WAS CRACKED AND THERE WAS CRYSTALLIZATION ON THE OUTSIDE OF THE FILTER WHICH APPEARED IT WAS LEAKING FOR AN EXTENDED PERIOD. IT WAS CONFIRMED DURING FOLLOW UP THAT THERE WAS NO DELAY IN PATIENT CARE, AND THAT THIS EVENT DID NOT CONTRIBUTE TO, OR RESULT IN A SERIOUS ADVERSE IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9831766 ↗MalfunctionJan 6, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING LEAKED AT THE PRESSURE DISK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9555569 ↗MalfunctionJan 6, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING LEAKED AT THE PRESSURE DISK, AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9554965 ↗MalfunctionJul 17, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE NICU FILTER CRACKED AT AN UNSPECIFIED LOCATION AND LEAKED WHEN INFUSING TPN. THE RN NOTICED THE SET LEAKING INTO THE PATIENTS BED AT THE TIME OF THE EVENT. THERE WAS NO HARM CAUSED TO THE PATIENT FROM THIS EVENT AND THE TUBING WAS CHANGED. A PHOTO RECEIVED FROM LAB WITH A NOTE ON PACKAGING STATED: "CRACKED FILTER TPN LINE, LEAKING ON PATIENTS BED EVENT /TIME''.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8800657 ↗MalfunctionFeb 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE PRODUCT POSSIBLY LEAKED DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8364802 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE FILTER LEAKED. A LABEL RECEIVED WITH THE SET STATED THE PRODUCT WAS TO BE CHANGED (B)(6) AT 1700. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8323050 ↗MalfunctionFeb 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A FILTER LEAKED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018, AND NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8322217 ↗MalfunctionFeb 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A FILTER INFUSING TPN LEAKED AT "THE MIDDLE PART OF THE ROUND FILTER ON THE BACK", ON AN INFANT WITH RESPIRATORY DISTRESS SYNDROME AND R/O SEPSIS. THE TPN WAS INFUSING THROUGH A TRIFUSE OF A UVC (UMBILICAL VENOUS CATHETER). THE LEAK WAS NOTICED QUICKLY BY THE NURSE; NO INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8309587 ↗MalfunctionJan 7, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A FILTER LEAKED "AT THE BACK OF THE ROUND PART" AND ON "THE SIDE WITHOUT THE LINES OF THE FILTER". THE LEAK WAS NOTICED 22 HOURS INTO THE TPN INFUSION. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8222036 ↗
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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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