Alaris, SmartSite 22059ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, Needle-free Valve (detachable), 23 cm (9 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403235016), received between Aug 26, 2019 and Apr 21, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 Leak2
- Leak/Splash2
- Material Rupture2
- Connection Problem1
- Defective Component1
- Device Contamination with Chemical or Other Material1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Connection Problem
IT WAS REPORTED BY CUSTOMER THAT THE J-LOOP EXTENSION SET WOULD NOT CONNECT TO THE PERIPHERAL INTRAVENOUS HUB CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944391 ↗MalfunctionNov 7, 2025Nonstandard Device; Defective Component; Nonstandard Device; 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 IT WAS REPORTED BY CUSTOMER THAT SET 22059E IS RUPTURING UNDER PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497560 ↗MalfunctionMay 20, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT EXT W/SS REM SPIN LUER & 1 SLD CLP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 22059E BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE DEVICE BLEW OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860788 ↗MalfunctionApr 23, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT EXT W/SS REM SPIN LUER & 1 SLD CLP HAD FLOW ISSUES. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT #: 1 MATERIAL #: 22059E BATCH/LOT #: UNKNOWN EVENT #: MATERIAL #: 22059E BATCH/LOT #: 21016366 IT WAS REPORTED THAT THE NEEDLE-FREE VALVE ON THE EXTENSION WOULD NOT OPEN. VERBATIM: THIS WEEKEND I HAD A COUPLE OF NURSES CALL ME FROM THE ED. THEY SAID THAT THE NEEDLE-FREE VALVE ON THESE EXTENSIONS WOULD NOT OPEN ON ABOUT 30% OF THE PRODUCT. WHEN INQUIRED THAT MAYBE WE RECEIVED A BAD CASE THEY SAID THEY HAVE BEEN HAVING THIS ISSUE FOR SEVERAL WEEKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11721090 ↗MalfunctionAug 26, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
MalfunctionAug 26, 2019Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
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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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