BD SmartSite 10013365Recalls & reported problems
BD Switzerland Sàrl · Add-On Bag Access Device Needle-Free Valve, Bag Access Port, Spike Adapter, Nonvented 93.5 cm (4 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613203010412), received between Dec 7, 2018 and Sep 12, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage3
- Fluid/Blood Leak3
- Leak/Splash3
- Material Separation2
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem
IT WAS REPORTED THAT BD SMARTSITE BAG ACCESS DEVICE WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WAS SEPARATED IT WAS REPORTED BY THE CUSTOMER THAT THE SPIKE CAME OUT OF THE BAG RESULTING IN A CHEMOTHERAPY SPILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038648 ↗MalfunctionFeb 6, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18655299 ↗MalfunctionJan 9, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18476360 ↗MalfunctionNov 7, 2023Complete Blockage; Complete Blockage
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: 10013365 BATCH #: (10)22115487. IT WAS REPORTED BY CUSTOMER THAT SMART-SITE BD SPIKE NOT ALLOWING FLUSH TO BE PUSHED INTO MEDICATION BAG. STAFF NEEDED TO SWITCH BAG OF SALINE TO FLUSH MEDICATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SMART-SITE BD SPIKE NOT ALLOWING FLUSH TO BE PUSHED INTO MEDICATION BAG. STAFF NEEDED TO SWITCH BAG OF SALINE TO FLUSH MEDICATION. PHOTOS INCLUDED AND SUPPLIES KEPT TO VIEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18083375 ↗MalfunctionJan 10, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED BD SMARTSITE ADD-ON BAG ACCESS DEVICE HAD BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV SPIKE TO DRAW UP PROPOFOL ARE NOT WORKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13205863 ↗MalfunctionJan 10, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED BD SMARTSITE ADD-ON BAG ACCESS DEVICE HAD BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO USE THIS DEVICE FOR DELIVERY OF PROPOFOL. NOT INTENDED FOR USE TO SPIKE BOTTLES OF PROPOFOL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13204560 ↗MalfunctionSep 9, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SMARTSITE ADD-ON BAG ACCESS DEVICE TUBING SEPARATED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10013365, BATCH NO: 18034603. IT WAS REPORTED TUBING LINE COMPLETELY SEPARATED WHEN SPIKE FELL OUT OF 50 ML BAG FILLED WITH METHOTREXATE, ALLOWING CONTENTS TO SPILL OUT. CUSTOMER EMAIL (B)(6) 2020: SORRY IT¿S TAKEN A BIT TO GET BACK WITH YOU. PER OUR SAFETY REPORT AND SPEAKING WITH STAFF, THE CONTENTS OF A 50ML METHOTREXATE BAG SPILLED FROM THE SPIKE AFTER IT FELL OUT OF A 50ML BBRAUN PAB BAG. THE EVENT WAS ON THE MORNING OF (B)(6) 2020. NO PATIENT WAS HARMED DUE TO THIS FROM SPEAKING WITH THE CHARGE NURSE OVER THE AREA, AND THE SPILL WAS CONTAINED AND CLEANED WITH A CHEMOTHERAPY SPILL KIT. DUE TO THE NATURE OF THE SPILL, WAS INFORMED THE PRODUCT LINE SET AND BAG WERE DISPOSED AT TIME OF SPILL CLEANUP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10512327 ↗MalfunctionSep 18, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ETOPOSIDE LEAKED FROM THE TUBING AND A NURSE WAS EXPOSED TO THE CHEMOTHERAPY WHEN SHE INVERTED THE BAG TO CONTAIN THE SPILL. AS A RESULT, THE ETOPOSIDE RAN DOWN HER ARM. THE SPILL WAS CLEANED UP PER FACILITY PROTOCOL, AND NO SKIN IRRITATION OR ADVERSE EFFECTS WERE REPORTED BY THE NURSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9080274 ↗MalfunctionDec 7, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
THE CUSTOMER REPORTED THAT THE WHITE PART BELOW THE SPIKE OF THE DEVICE SEPARATED FROM THE CLEAR PART WHERE IT WAS INTENDED TO BE BONDED. THE NURSE WAS SETTING UP A CHEMOTHERAPEUTIC INFUSION IN A PUMP AND IT SEPARATED WHEN HUNG. THE NURSE WAS EXPOSED, TOOK A SHOWER, DONNED NEW CLOTHING AND WENT TO THE EMPLOYEE HEALTH. THERE WAS NO PATIENT OR STAFF HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8143577 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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