Alaris, SmartSite 20043ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, High Flow T-Connector with Needle-Free Valve, 15 cm (6 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 intravenous tubing used to deliver fluids or medicines. Reports mostly describe leaks or splashes and tubing or connectors cracking, separating, breaking, or collapsing; one report mentions blood loss. There are 25 reports, including no deaths and 1 injury. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10885403234873), received between Jul 12, 2019 and May 23, 2025 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (14 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
- Leak/Splash14
- Crack6
- Fluid/Blood Leak5
- Material Separation3
- Break1
- Connection Problem1
- Defective Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Information4
- Insufficient Information3
- Blood Loss1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22078802 ↗MalfunctionMay 28, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19412397 ↗MalfunctionMay 6, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM PRODUCT DESCRIPTION: SMARTSITE EXTENSION SET ORIGIN OF THE ISSUE: PRODUCT FAILURE//DESIGN DETAIL: EXTENSION TUBING PULLED APART AT THE CONNECTION POINT TO THE SMARTSITE VALVE.
Patient problems: Insufficient Information
MAUDE report 19249833 ↗MalfunctionMar 12, 2024Material Separation; Material Separation
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIALS: 20043E BATCH#: 23125339 IT WAS REPORTED BY THE CUSTOMER THAT EXTENSION TUBING PULLED APART AT THE CONNECTION POINT TO THE SMARTSITE VALVE. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. FACILITY CONTACT: (B)(6) DEPARTMENT: MATERIALS MANAGEMENT PHONE NUMBER: (B)(60 EMAIL: (B)(6) PRODUCT CATALOG NUMBER: 20043E PRODUCT DESCRIPTION: SMARTSITE EXTENSION SET ORIGIN OF THE ISSUE: PRODUCT FAILURE//DESIGN DETAIL: EXTENSION TUBING PULLED APART AT THE CONNECTION POINT TO THE SMARTSITE VALVE. NUMBER OF OCCURRENCES: 1.0 SAMPLE AVAILABLE: TRUE LOT NUMBER: 23125339 REPORTED TO VENDOR REPRESENTATIVE: YES
Patient problems: Insufficient Information
MAUDE report 18887438 ↗MalfunctionMar 11, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882978 ↗MalfunctionNov 21, 2023Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD HI-FLOW EXT SET WAS COLLAPSED/KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: OUR PEDS ICU/WARD HAS AN ISSUE WITH MFR# - 20043E SMALL BORE IV EXTENSION SET WITH SLIDE CLAMP, SMARTSITE T-CONNECTOR, SPIN MALE LUER LOCK, 6", 0.4 ML PRIMING VOLUME. THE ISSUE IS THE TUBE COLLAPSING DURING BLOOD DRAWS.
Patient problems: Insufficient Information
MAUDE report 18188238 ↗MalfunctionJun 27, 2023Defective Component; Defective Component
IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ SMARTSITE¿ EXTENSION SET THE PRESSURE INJECTOR CAUSED A PIECE IN THE SMARTSITE TO POP OUT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV EXTENSION SET FAILURE (20043E DURING POWER-INJECTION). WE HAD A IV EXTENSION SET FAIL IN CT RECENTLY, WHERE THE PRESSURE INJECTOR CAUSED THE INTERNAL BLUE PIECE IN THE SMART SITE TO POP OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17213943 ↗MalfunctionJun 8, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES CAT# 20043# LOT # 22105095 HAD A LEAKAGE ISSUE AT THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17088391 ↗MalfunctionMay 1, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET POPPED OUT CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLUE, INTERNAL VALVE POPPED OUT, CAUSING CONTRAST TO LEAK/SPRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16850304 ↗MalfunctionJan 17, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO LET YOU KNOW THAT WE HAD TWO ADDITIONAL 20043E EXTENSION SETS THAT WERE FOUND LEAKING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16186943 ↗MalfunctionDec 28, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED NOTICE OF AN EXTENSION SET THAT WAS LEAKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16065646 ↗MalfunctionDec 22, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET, SMALLBORE SLIDE CLAMP WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE NOTICED THE FIRST ONE LEAKING, SWITCHED TO ANOTHER ONE THAT WAS STILL LEAKING, AND FINALLY GOT A THIRD ONE OUT THAT DIDN¿T LEAK. IT WAS CONNECTED TO A CLAVE THAT WAS CONNECTED TO A NORMAL SALINE FLUSH. IT WAS LEAKING THE NORMAL SALINE, AND WAS DISCOVERED WHEN PRIMING THE TUBING PRIOR TO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16039973 ↗MalfunctionDec 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT MEDICATION LEAKED BETWEEN THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET AND ICU MEDICAL MICROCLAVE CONNECTOR DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING DRUG BETWEEN THE CONNECTION OF THE BD SMARTSITE EXTENSION SET AND THE ICU MEDICAL MICROCLAVE CONNECTOR. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE REPORTED FAILURE?- NO."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973669 ↗MalfunctionDec 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT MEDICATION LEAKED BETWEEN THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET AND ICU MEDICAL MICROCLAVE CONNECTOR DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING DRUG BETWEEN THE CONNECTION OF THE BD SMARTSITE EXTENSION SET AND THE ICU MEDICAL MICROCLAVE CONNECTOR. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE REPORTED FAILURE?- NO"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973599 ↗MalfunctionDec 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT MEDICATION LEAKED BETWEEN THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET AND ICU MEDICAL MICROCLAVE CONNECTOR DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING DRUG BETWEEN THE CONNECTION OF THE BD SMARTSITE EXTENSION SET AND THE ICU MEDICAL MICROCLAVE CONNECTOR. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE REPORTED FAILURE?- NO".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973597 ↗MalfunctionDec 8, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD SMARTSITE¿ EXTENSION SET, SMALLBORE SLIDE CLAMP WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED ANOTHER REPORT OF A LEAKING 20043E EXTENSION SET THIS TIME AT WESTERN RIDGE MEDICAL CENTER (INFUSION CENTER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15946232 ↗MalfunctionDec 8, 2022Leak/Splash
IT WAS REPORTED WHILE USING SMARTSITE¿ EXTENSION SET, SMALLBORE SLIDE CLAMP LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD ANOTHER REPORT OF A LEAKING EXTENSION SET. IT LOOKS LIKE THERE WAS LEAKING AT THE CONNECTION POINT BETWEEN THE NEEDLELESS CONNECTOR AND LUER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15938838 ↗MalfunctionDec 3, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECENTLY HAD A REPORT OF A LEAKING EXTENSION SET. IT LOOKS LIKE AFTER THE EXTENSION SET WAS FOUND TO BE LEAKING, THE NEEDLESS CONNECTOR WAS CHANGED AND IT CONTINUED TO LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15912090 ↗MalfunctionJul 9, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HI-FLOW T-CONN W/LL & 1 VLV PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM NEEDING A CASE NUMBER FOR ABOVE MENTIONED DEVICE. WHEN PULLED FORM PACKAGING AND PRIMED FOR PATIENT USE, FOUND TO BE LEAKING AT COLLAR. I HAVE THE TIME AND THE PACKAGING. WAS NOT ACTUALLY USED IN PATIENT CARE AS ANOTHER ITEM WAS OBTAINED FOR USE. DATE OF EVENT IS ON (B)(6).
Patient problems: No Patient Involvement
MAUDE report 10252059 ↗MalfunctionMar 9, 2020Crack; Crack
IT WAS REPORTED THAT THE T-CONNECTOR CRACKED ON THE NEONATAL INTENSIVE [NICU] CARE UNIT. THE CRACK OCCURRED DURING A PICC LINE T-CONNECTOR CHANGE OUT - THE T-CONNECTOR CRACKED DURING STERILE CAP CHANGE. THE ALARIS LVP WAS INFUSING D12.5 1/2NS +10MEQ/L KCL+ 0.5UNIT/ML HEPARIN. NO HEMOSTATS WERE USED DURING THE CHANGE OUT. THIS DID NOT IMPACT THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9806865 ↗InjuryJul 22, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AND CAUSED SIGNIFICANT BLOOD LOSS WHEN CONNECTED TO THE ARTERIAL LINE OF A NEO-NATAL PATIENT. THE INFANT LOST APPROXIMATELY 40ML OF BLOOD AND REQUIRED A BLOOD TRANSFUSION. THERE WAS NO LASTING HARM.
Patient problems: Blood Loss
MAUDE report 8811769 ↗MalfunctionJul 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE EXTENSION TUBING SET CRACKED AT THE DISTAL PORTION AND CAUSED BLOOD TO LEAK.
Patient problems: No Information
MAUDE report 8787042 ↗MalfunctionJul 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE EXTENSION TUBING SET CRACKED AT THE DISTAL PORTION AND CAUSED BLOOD TO LEAK.
Patient problems: No Information
MAUDE report 8786747 ↗MalfunctionJul 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE EXTENSION TUBING SET CRACKED AT THE DISTAL PORTION AND CAUSED BLOOD TO LEAK.
Patient problems: No Information
MAUDE report 8786746 ↗MalfunctionJul 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE EXTENSION TUBING SET CRACKED AT THE DISTAL PORTION AND CAUSED BLOOD TO LEAK.
Patient problems: No Information
MAUDE report 8786634 ↗
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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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