BD SmartSite 4030B-07TRecalls & reported problems
BD Switzerland Sàrl · Low Sorbing Secondary Set, 0.2 Micron Low Protein Binding Filter, Needle-Free Valve Bag Access Port, Closed Male Luer, Priming Cap (orange colored), Hanger Nonvented 81 cm (32 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403240867), received between Mar 4, 2024 and Sep 12, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 reports).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- May 12, 2025Open, Classified
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Z-1970-2025 · Root cause: Process control · Recall details · FDA record ↗
- Oct 11, 2023Open, Classified
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Z-0350-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash3
- Material Separation2
- Air/Gas in Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Leak/Splash; Leak/Splash
CUSTOMER PROVIDED EVENT DATES RELATED TO 3 DIFFERENT DEVICES BUT WAS UNABLE TO ATTRIBUTE THE DATES TO ANY SPECIFIC DEVICE. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038817 ↗MalfunctionMar 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE TEXIUM LOW SORBING SECONDARY SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARKLAND HAS HAD ONGOING LEAKING TEXIUM SETS, PRIMARILY WITH DOXIRUBICIN AND OTHER HAZARDOUS DRUGS / CHEMO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21615612 ↗MalfunctionMar 5, 2025Air/Gas in Device; Air/Gas in Device
MATERIAL # 4030B-07T BATCH #24059484 IT WAS REPORTED BY CUSTOMER THAT THE TUBING PULLING AIR CAUSED AIR IN LINE ERROR BUT THERE WAS STILL FLUID IN THE DRIP CHAMBER VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED TUBING PULLING AIR CAUSED AIR IN LINE ERROR BUT THERE WAS STILL FLUID IN THE DRIP CHAMBER PRODUCT NUMBER - 4030B-07T CUSTOMER RESPONDED ON 17-FEB-2025 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO KNOWN HARM 2. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? HAVE THE PREVIOUS ISSUES BEEN REPORTED TO BD? IF SO, PLEASE PROVIDE THE COMPLAINT REFERENCE NUMBER. IF NOT, KINDLY ANSWER THE FOLLOWING QUESTIONS: 1.COULD YOU PLEASE PROVIDE THE EXACT DATE OF THE EVENT IN THE FORMAT MM-DD-YYYY? THE DATE OF SUBMISSION WOULD BE THE DATE IT OCCURRED - I SUBMITTED 2 ISSUES AND I'M NOT SURE WHICH ONE THIS IS OR WHAT DATE IT HAPPENED 2.PLEASE SHARE THE MATERIAL AND LOT NUMBER ASSOCIATED WITH THE REPORTED ISSUE. THIS WAS INCLUDED IN THE REPORT - I NO LONGER HAVE THIS INFORMATION. 3.DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529833 ↗MalfunctionDec 5, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20853485 ↗MalfunctionAug 14, 2024Material Separation; Material Separation
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983309 ↗MalfunctionMar 4, 2024Material Separation; Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM LOW SORBING SECONDARY SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THE FILTER PORTION OF THE SECONDARY SET FELL OFF DURING VERIFICATION. THIS IS THE 2ND ITEM WE'VE HAD LIKE THIS, BUT I AM UNSURE IF IT IS THE SAME OR DIFFERENT LOT. PATIENT HERE LONGER THAN NECESSARY, MORE WORK INVOLVED THAN NECESSARY, WASTE. ITEM#4030B-07T. LOT#23039083.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18827279 ↗
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- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 · each recall links to the FDA recall notice
- 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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