Alaris, SmartSite 20051ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, T-Connector with Needle-Free Valve, Slip Luer, 15 cm (6 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613203012331), received between Dec 3, 2019 and Feb 26, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 Leak5
- Leak/Splash5
- Crack3
- Component Missing1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- Insufficient Information1
- Intimal Dissection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Crack
NO ADDITIONAL INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24460064 ↗MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE PART OF THE EXTENSION HALL WILL LEAK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535794 ↗MalfunctionAug 13, 2024Leak/Splash; 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: THE PRODUCT LEAKS FROM AN UNKNOWN LOCATION AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19975341 ↗MalfunctionAug 11, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET TUBING WAS MISSING.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO EXTENSION TUBE, ONLY HUB, CLAMP IN THE PACKAGE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15212245 ↗MalfunctionSep 27, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBE LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533657 ↗MalfunctionJul 23, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT T-CONN W / LUER SLIP ADPT TUBING WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS SMARTSITE TUBING TORN INTO TWO. SMARTSITE 20051E WAS TORN INTO TWO PIECES WHEN DISTRIBUTOR STRETCHING THE TUBING BY HAND TO SHOW ITS STRENGTH AND FLEXIBILITY.
Patient problems: No Patient Involvement
MAUDE report 10315973 ↗MalfunctionJun 25, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT T-CONN W/LUER SLIP ADPT TUBING WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING IS SEVERED AT THE EDGE OF POUCH WITH COMPLETE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10198142 ↗MalfunctionApr 6, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 32 T-CONNS W/LUER SLIP ADPT EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FLUID WAS COMING OUT FROM THE DEFORMED OVAL CONNECTOR END. THE SMARTSITE NEEDLE-FREE CONNECTOR END IS CLEARLY DEFORMED INTO OVAL SHAPE (SHOULD BE ROUND SHAPE). FLUID WAS COMING OUT FROM THE DEFORMED OVAL CONNECTOR END. AFFECTED QUANTITY: 32 EA.
Patient problems: Intimal Dissection; No Consequences Or Impact To Patient
MAUDE report 9930960 ↗MalfunctionDec 19, 2019Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
THE REPORTED FEEDBACK SUGGESTS THAT THE SMARTSITES ARE DEFORMED. REPORT SUGGESTS NOT IN USE ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9497009 ↗MalfunctionDec 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE REPORTED FEEDBACK SUGGESTS THAT THE FEMALE LUER ADAPTER END HAD A VISIBLE CRACK WHICH CAUSED BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9492038 ↗MalfunctionDec 18, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE REPORTED FEEDBACK SUGGESTS THAT THE FEMALE LUER ADAPTER END HAD A VISIBLE CRACK WHICH CAUSED BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9492014 ↗MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE REPORTED FEEDBACK SUGGESTS THAT BLOOD WAS COMING OUT FROM THE DEFORMED OVAL CONNECTOR END.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9403233 ↗
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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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