Alaris 10013364TRecalls & reported problems
BD Switzerland Sàrl · Secondary Set, Bag Access Port, Nonvented Drip Chamber, 81 cm (32 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Alaris secondary set is an IV tubing set used to give a second medicine through an IV line. Its 141 reports often describe leaks at the connections, and some describe chemotherapy spills. There are no deaths and 2 injuries. 1 recall, still open, began in May 2025 over connection leaks that can expose staff to hazardous drugs. Reports fell to 0 in the last 12 months from 42 before.
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
- 141
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 10885403198915), received between Apr 18, 2019 and Jul 17, 2025 — classified as 2 injuries, 139 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (76 reports).
1 FDA recall record name this device's identifier, 1 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 18, 2026.
Reports received per month
Recalls naming this device
- May 12, 2025Class IIOpen, 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 ↗
Most reported problems
Device problems
- Leak/Splash76
- Material Separation27
- Separation Problem13
- Fluid/Blood Leak9
- Defective Component8
- Break5
- Component Missing3
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions123
- Chemical Exposure8
- No Consequences Or Impact To Patient6
- No Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Crack; Crack
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT CODE ORANGE WITH SECONDARY SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536675 ↗MalfunctionMay 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT AFTER CONNECTING THE TEXIUM SECONDARY SET TO THE PRIMARY LINE AND STARTING THE INFUSION, OBSERVE THAT CONNECTION DOES NOT LEAK. LEAKING HAS BEEN REPORTED TO OCCUR SHORTLY AFTER THE START OF THE INFUSION. THE GREEN CONNECTION PIECE ON THE END OF OUR HAZARDOUS SECONDARY SET DOES NOT SEEM TO CREATE A PERFECT SEAL WITH THE SMARTSITE PORT WHEN CONNECTED TO A PRIMARY LINE. SOME LEAKS HAVE BEEN A SINGLE DROP FORMING OVER A 5-10 MINUTE PERIOD OF TIME. OTHER LEAKS HAVE BEEN FASTER, CAUSING AIR TO ENTER THE LINE AND HAZARDOUS MEDICATION TO DRIP DOWN THE LINE. REATTACHING AND TIGHTENING THE CONNECTIONS DID NOT STOP THE LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962798 ↗MalfunctionApr 3, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS MISSING A COMPONENT. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED: 'PATIENT IN TREATMENT FOR C10D1 TAXOL. PREMEDS GIVEN. RN RETRIEVED TAXOL FOR INFUSION. UPON TAKING TAXOL BAG OUT OF BIOHAZARD BAG, THIS RN NOTICED THAT TAXOL WAS PRIMED ON A SECONDARY LINE WITHOUT ANY FILTERING. RN TOOK TAXOL BACK TO PHARMACY. (B)(6) EXAMINED TAXOL AND AGREED IT WAS WRONG TUBING. TAXOL REMADE ON CORRECT PRIMARY TUBING WITH FILTER. TAXOL INFUSED WITHOUT ISSUE. PRODUCT NUMBER - 10013364T'.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763276 ↗MalfunctionApr 3, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED: 'NURSE REPORTED THAT ARSENIC BAG WAS LEAKING. SHE CONFIRMED WITH SECOND NURSE THAT 54 ML WAS REMAINING WHEN STARTED LEAKING. CLINIC PHARMACIST NOTIFIED. PRODUCT NUMBER - 10013364T'.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763256 ↗MalfunctionApr 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED: "PT RECEIVING DACOGEN THROUGH 22G PIV, UPON UNHOOKING PT AFTER 1 HOUR INFUSION + 20 MINUTE FLUSH, LEAKING NOTICED ON PT'S PANTS. UNABLE TO VERIFY THE SOURCE OF THE LEAK, BUT DO NOT BELIEVE IT WAS FROM IV INSERTION SITE. DOUBLE CHECKED TUBING AND TEXIUM EXTENSION BUT NOT ABLE TO IDENTIFY SPECIFIC SOURCE OF THE LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753509 ↗MalfunctionApr 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED: "DECITABINE INFUSION WAS STARTED AT 1024 AND CHECKED BY XXXX, RN. THIS RN WENT TO GET THE PATIENT A SNACK, UPON RETURN TO THE PATIENT'S ROOM, THIS RN CHECKED CHEMOTHERAPY TUBING AND NOTICED SMALL DRIPS LEAKING FROM THE SECONDARY LINE ON THE DECITABINE TUBING VIA THE GREEN TEXIUM ATTACHMENT ONTO THE TOP OF THE INFUSION PUMP. INFUSION WAS STOPPED AND CHARGE NURSE XXXX, RN WAS NOTIFIED. PURPLE TEAM NOTIFIED AND NEW ORDERS WERE PLACED FOR DECITABINE INFUSION TO BE REMADE. PHARMACY NOTIFIED OF LEAKING AND CHEMOTHERAPY RETURNED TO PHARMACY FOR INSPECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21752930 ↗MalfunctionApr 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. PATIENT CAME FOR TREATMENT FROM INPATIENT FLOOR. PATIENT WHILE RECEIVING TREATMENT. WRITER NOTICED CHEMO HAD SPILLED ON FLOOR. WRITER OBSERVED THAT LEAKING WAS COMING FROM THE TUBING FROM LOOKING WHERE TEXIUM CONNECTS WAS DEFECTIVE. VERY SMALL DROPS WERE COMING AS WRITER DID NOT NOTICE THIS WHILE CHEMO WAS INITIALLY BEING HUNG. CHEMO SPILL CLEANED AS PER PROTOCOL. MD INFORMED. PHARMACY NOTIFIED AS IT WAS PREPPED IN ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21751296 ↗MalfunctionMar 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PATIENT WAS STARTED ON CYCLOPHOSPHAMIDE MEDICATION, COLLEAGUE NURSES NOTICED LEAKAGE OF MEDICATION FROM TEXIUM PART OF TUBING. APPROXIMATELY 50CC OF MEDICATION WAS WASTED. SPILL MANAGEMENT/ CLEAN UP WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735715 ↗MalfunctionMar 31, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE TEXIUM FROM THE SECONDARY LINE OF IRINOTECAN BAG WAS LEAKING, DRIPPING DOWN TO THE FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735713 ↗MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735712 ↗MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: LEAK IN TUBING DURING ISAT INFUSION. FEW DROPS NOTICED ON FLOOR AND TUBING DURING PATIENT CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735608 ↗MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735607 ↗MalfunctionMar 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM NURSE REPORTED OXALIPLATIN SPILL. OXALIPLATIN WAS MIXED IN 250ML D5W BAG WITH SECONDARY TUBING. THE SECONDARY TUBING SNAPPED AT THE TUBING CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21698673 ↗MalfunctionMar 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657384 ↗MalfunctionMar 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT TUBING LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620538 ↗MalfunctionMar 11, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580222 ↗MalfunctionMar 11, 2025Leak/Splash; Leak/Splash
IMDRF CODES MUST BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580199 ↗MalfunctionMar 6, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543523 ↗MalfunctionMar 5, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE GREEN CAP THAT IS BONDED TO END OF SECONDARY SET BEGAN LEAKING AS A CHEMOTHERAPY MIX WAS FINISHING UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529968 ↗MalfunctionFeb 19, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT CHEMO SECONDARY TUBING FELL APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21412603 ↗MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT SECONDARY (GREEN CAP HOOKUP FOR HAZARDOUS DRUGS) LEAKING AFTER BEING HOOKED UP TO PRIMARY LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21412502 ↗MalfunctionFeb 18, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS DEFECTIVE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE ROLLER CLAMP IS ATTACHED UPSIDE DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21402460 ↗MalfunctionFeb 12, 2025Leak/Splash; Defective Component; Leak/Splash; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370686 ↗MalfunctionFeb 7, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SMARTSITE TEXIUM SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THERE WAS ANOTHER CHEMO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334693 ↗MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294698 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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