BD SmartSite 2309ERecalls & reported problems
BD Switzerland Sàrl · Bag Access Device, Check Valve Needle-Free Valve, 13 cm (5 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613203011655), received between Dec 15, 2020 and Sep 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage2
- Leak/Splash1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763182 ↗MalfunctionJan 9, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT BAG ACCESS DEVICE W/CKV WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 2309E BATCH/ LOT #: 20076260 ((B)(4) PROVIDED BUT INVALID). IT WAS REPORTED THAT ONCE THE IV BAG IS SPIKED WITH THE SMARTSITE BAG ACCESS DEVICE, THE NURSE CANNOT PULL BACK FLUID FROM THE BAG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11143927 ↗MalfunctionDec 15, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A BAG ACCESS DEVICE W/CKV HAD DAMAGED OR DEFECTIVE TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS AN ISSUE WITH THE SMARTSITE BAG ACCESS DEVICE. ONCE THE IV BAG IS SPIKED WITH THE SMARTSITE BAG ACCESS DEVICE, THE NURSE CANNOT PULL BACK FLUID FROM THE BAG." VERBATIM: CAN WE PLEASE CONNECT WITH CHAD AT LA COUNTY TO RESOLVE THE MATTER WITH ITEM #2309E."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11009539 ↗
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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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