Alaris, SmartSite 30202ERecalls & reported problems
BD Switzerland Sàrl · Extension Set, Needle-Free Valve 51 cm (20 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613203011532), received between Nov 5, 2020 and Sep 2, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component2
- Fluid/Blood Leak1
- Leak/Splash1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
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 THE EXTENSION SET DISCONNECTED BY ITSELF FROM THE IV HUB, CAUSING A BLOOD EXPOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22935373 ↗MalfunctionApr 18, 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: RCC RECEIVED A COMPLAINT VIA EMAIL. WE ARE ENCOUNTERING AN ISSUE WITH THE IV EXTENSION TUBING CONFIGURATION. THE PORTS ON THE TUBING ARE UPSIDE DOWN. NOT SURE IF THIS IS A BATCH ISSUE OR PRODUCT CHANGE BUT IT IS IMPACTING OUR ANESTHESIA PROVIDERS. ITEM#30202E. SERIEL NUMBER:(B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19134041 ↗MalfunctionApr 16, 2024Defective Component; Defective Component
MalfunctionJun 7, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT THE BD EXTENSION SETS - 20" STANDARD-BORE IV EXTENSION SET HAS A DIFFERENT IDENTIFICATION THAN THE BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRONG PRODUCTS BOXED IN THE CASE OF PRODUCT "CASE OF ITEM 30202E, IN THE CASE WAS ITEM 22059E(12 EA.) " (PER CUSTOMER).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17078821 ↗MalfunctionNov 5, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE 20 INCH EXT W/1 VLV PORT LEAKED CHEMO DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WANTED TO BRING TO YOUR ATTENTION THAT WHEN WE WERE USING THE TUBING SUBSTITUTION FOR CHEMO A FEW WEEKS AGO WE HAD A FAILURE AND HAD A MAJOR CHEMO SPILL. NO ONE WAS HARMED BUT THE PRODUCTS WERE 26603-B007T AND THE EXTENSION SET 30202E. CHEMO LEAKED BETWEEN THE PUMP INFUSION SET AND THE EXTENSION SET." "THE CHEMO SPILL OCCURRED ON (B)(6) 2020 IN OUR INFUSION CENTER. WHAT HAD HAPPENED WAS A NURSE HAD ADMINISTERED THE CHEMO TO THE PATIENT. WHEN SHE CAME BACK TO CHECK ON THE PATIENT SHE NOTICED DRUG WAS LEAKING FROM WHERE THE PUMP INFUSION SET WAS CONNECTED TO THE SMARTSITE EXTENSION SET. THE LINE WAS CLAMPED OFF APPROPRIATELY AND NO CHEMO ACTUALLY SPILLED ONTO THE PATIENT JUST ON THE FLOOR. WE FOLLOWED OUR PROTOCOL TO CLEAN UP A HAZARDOUS DRUG SPILL AND NO HARM WAS DONE TO THE PATIENT. THE PRODUCT NUMBERS ARE 22603-B007T FOR THE INFUSION SET WITH LOT# (10)20086389 AND 30202E FOR EXTENSION SET LOT # (10)20026464."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10795819 ↗
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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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