BD SmartSite 70001B-07TRecalls & reported problems
BD Switzerland Sàrl · Low Sorbing Secondary Set Needle-Free Valve Bag Access Port, Closed Male Luer, Nonvented, Priming Cap (orange colored) Hanger 79 cm (31 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.
Quick summary
This BD SmartSite secondary infusion set is used to deliver fluids or drugs into a vein. The 34 reports that name its identifier mostly describe liquid leaking at the connector during infusion, sometimes delaying treatment. There were no deaths and no injuries. It has 2 open recalls, one for leaking at the luer connection and one because sets labeled DEHP-free actually contain DEHP.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10885403240997), received between May 10, 2023 and Jun 15, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (26 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-0351-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash26
- Fluid/Blood Leak5
- Complete Blockage1
- Component Missing1
- Defective Component1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Chemical Exposure1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Leak/Splash
IT WAS REPORTED THAT THE BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING AT GREEN TEXIUM BONDED SITE DURING ADMINISTRATION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE IMPACT TO THE PATIENT? INFUSION WAS SLIGHTLY DELAYED. A PHARMACY STAFF HAD TO COME IN OVERNIGHT TO REPLACE THE ADMINISTRATION LINE IN ORDER FOR PROPER INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25510773 ↗MalfunctionMay 29, 2026Leak/Splash
IT WAS REPORTED THAT THE BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MANY REPORTS RECEIVED IN REGARDS TO BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT REF # 70001B-07T. 5 REPORTS TOTAL REPORTED IN TERMS OF LEAKING. ONE REPORT INVOLVED STARTING A PIGGYBACK INFUSION OF FLUOROURACIL 900MG, A LEAK OCCURRED AT THE CONNECTOR SITE TO THE PRIMARY IV LINE. APPROXIMATELY 5 ML OF FLUID LEAKED, BUT NONE CAME INTO CONTACT WITH THE PATIENT. THE LEAK WAS CONTAINED WITH A DISPOSABLE PAD. PHARMACY WAS NOTIFIED. SIMILAR EVENTS COULD OCCUR AT OTHER FACILITIES USING THE SAME BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT IF THERE ARE PRODUCT DEFECTS, COMPATIBILITY ISSUES, OR ASSEMBLY ERRORS. IF LEAKAGE OCCURS WITH HAZARDOUS DRUGS LIKE CHEMOTHERAPY, STAFF COULD BE EXPOSED TO CYTOTOXIC FLUIDS, PRESENTING HEALTH RISKS SUCH AS SKIN IRRITATION OR LONG-TERM EFFECTS. ADDITIONALLY, MEDICATION LOSS COULD LEAD TO UNDERDOSING, IMPACTING PATIENT CARE. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEGA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337618 ↗MalfunctionMay 29, 2026Leak/Splash
IT WAS REPORTED THAT THE BD TEXIUM SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MANY REPORTS RECEIVED IN REGARDS TO BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT REF # (B)(4). 5 REPORTS TOTAL REPORTED IN TERMS OF LEAKING. ONE REPORT INVOLVED STARTING A PIGGYBACK INFUSION OF FLUOROURACIL 900MG, A LEAK OCCURRED AT THE CONNECTOR SITE TO THE PRIMARY IV LINE. APPROXIMATELY 5 ML OF FLUID LEAKED, BUT NONE CAME INTO CONTACT WITH THE PATIENT. THE LEAK WAS CONTAINED WITH A DISPOSABLE PAD. PHARMACY WAS NOTIFIED. SIMILAR EVENTS COULD OCCUR AT OTHER FACILITIES USING THE SAME BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT IF THERE ARE PRODUCT DEFECTS, COMPATIBILITY ISSUES, OR ASSEMBLY ERRORS. IF LEAKAGE OCCURS WITH HAZARDOUS DRUGS LIKE CHEMOTHERAPY, STAFF COULD BE EXPOSED TO CYTOTOXIC FLUIDS, PRESENTING HEALTH RISKS SUCH AS SKIN IRRITATION OR LONG-TERM EFFECTS. ADDITIONALLY, MEDICATION LOSS COULD LEAD TO UNDERDOSING, IMPACTING PATIENT CARE. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NEGATIVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334942 ↗MalfunctionApr 29, 2026Leak/Splash
IT IS REPORTED, BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT, LEAKING AROUND CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034188 ↗MalfunctionApr 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD ALARIS TEXIUM INFUSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT "LEAKING OCCURRED MULTIPLE TIMES IN THE PAST".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957684 ↗MalfunctionApr 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD TEXIUM EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT "LEAKING OCCURRED MULTIPLE TIMES IN THE PAST".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957019 ↗MalfunctionApr 10, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT UPON HOOKING THE MEDICATION UP, RN NOTICED LEAKING AT THE HOOK-UP SITE. ATTEMPTED TO RECONNECT AND STILL NOTICED LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844414 ↗MalfunctionApr 6, 2026Leak/Splash
IT WAS REPORTED THAT THE BD TEXIUM CLOSED MALE LUER HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED ANOTHER REPORT OF A LEAKING BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE-FREE VALVE BAG ACCESS PORT REF # 70001B-07T. UNFORTUNATELY, THE LOT# WAS NOT ABLE TO BE OBTAINED. THE EVENT HAPPENED ON 3/19/2026. I DO NOT HAVE ANY PICTURES OF THE EVENT. IT WAS AGAIN NOTED ON A DOXORUBICIN INFUSION FOR CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793631 ↗MalfunctionMar 24, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD EXTENSION TEXIUM SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT MULTIPLE LEAKAGE INCIDENTS HAVE BEEN REPORTED WITH THIS SPECIFIC INFUSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675645 ↗MalfunctionMar 24, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675621 ↗MalfunctionMar 24, 2026Fluid/Blood Leak; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675620 ↗MalfunctionMar 23, 2026Leak/Splash
IT IS REPORTED BD LOW SORBING SECONDARY SET SMARTSITE NEEDLE FREE VALVE BAG ACCESS PORT LEAKED. THE LEAK OCCURRED FROM THE BOTTOM END WHERE IT ATTACHED TO THE YSITE, BUT WAS UNABLE TO BE TIGHTENED ANY FURTHER.
Patient problems: Insufficient Information
MAUDE report 24665321 ↗MalfunctionFeb 18, 2026Leak/Splash
IT IS REPORTED LEAKAGE. PRIMARY OR SECONDARY TUBING WITH TEXIUM ENDS WOULD START LEAKING FROM THE CONNECTION POINT. LEAKS WOULD REGARDLESS OF HOW TIGHT THE CONNECTION WAS SECURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379978 ↗MalfunctionFeb 18, 2026Leak/Splash
IT IS REPORTED LEAKAGE. PRIMARY OR SECONDARY TUBING WITH TEXIUM ENDS WOULD START LEAKING FROM THE CONNECTION POINT. LEAKS WOULD REGARDLESS OF HOW TIGHT THE CONNECTION WAS SECURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379435 ↗MalfunctionFeb 18, 2026Leak/Splash
IT IS REPORTED LEAKAGE. PRIMARY OR SECONDARY TUBING WITH TEXIUM ENDS WOULD START LEAKING FROM THE CONNECTION POINT. LEAKS WOULD REGARDLESS OF HOW TIGHT THE CONNECTION WAS SECURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379434 ↗MalfunctionFeb 18, 2026Leak/Splash
IT IS REPORTED LEAKAGE. PRIMARY OR SECONDARY TUBING WITH TEXIUM ENDS WOULD START LEAKING FROM THE CONNECTION POINT. LEAKS WOULD REGARDLESS OF HOW TIGHT THE CONNECTION WAS SECURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24379433 ↗MalfunctionJan 20, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120708 ↗MalfunctionJan 20, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120691 ↗MalfunctionSep 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT CHEMO DRUGS HAVE BEEN LEAKING FROM THEM CAUSING SPILLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038832 ↗MalfunctionSep 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE CLOSED MALE LUER WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT CHEMO DRUGS HAVE BEEN LEAKING FROM THEM CAUSING SPILLS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23038830 ↗MalfunctionMay 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS, SMARTSITE TEXIUM LOW SORBING SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE CHECKING THE INTEGRITY OF THE TUBING AS INSTRUCTED BEFORE AND WHEN PRIMING. THE LEAK IS HAPPENING WELL INTO HAZARDOUS DRUG INFUSIONS.
Patient problems: Chemical Exposure
MAUDE report 22081712 ↗MalfunctionMay 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS TEXIUM SMARTSITE LOW SORBING SECONDARY SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMO RN CAME TO THE PHARMACY STATING KEYTRUDA IV PIGGYBACK LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079336 ↗MalfunctionMay 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKING SECONDARY AT THE TEXIUM CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049349 ↗MalfunctionMay 15, 2025Leak/Splash; Leak/Splash
MalfunctionMay 15, 2025Leak/Splash; Leak/Splash
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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 · 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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