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BD Texium 40000-07TRecalls & reported problems

BD Switzerland Sàrl · Secondary Set, 81 cm (32 in) · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This BD Alaris Texium secondary set is a short tubing set used to give IV drugs, including chemotherapy. The 43 reports mostly describe the tubing coming apart or leaking at the connection, sometimes while priming or in use, which one report says let a chemotherapy dose spill so the patient did not get the full amount. There are no deaths and no injuries. One recall, started in May 2025, remains open and cites leaking at the luer connector as a process control issue.

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
43
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10885403225628), received between Jan 13, 2021 and Sep 1, 2022 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (22 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. 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 · FDA record ↗

Most reported problems

Device problems

  • Leak/Splash22
  • Device Contamination with Chemical or Other Material7
  • Material Separation7
  • Detachment of Device or Device Component5
  • Separation Failure3
  • Separation Problem3
  • Fluid/Blood Leak1
  • Premature Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions41
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 1, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

    IT WAS REPORTED THAT THE BD ALARIS TEXIUM SECONDARY SET EXPERIENCED SEPARATION WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW THE DRIP CHAMBER WHILE IN USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15341441 ↗
  • MalfunctionJun 30, 2022Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD ALARIS TEXIUM SECONDARY SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONCERN DESCRIPTION: AFTER PREPARING HAZARDOUS DRUG AND DURING THE FINAL CHECK, THE TRANSFER SET FAILED AND FLUID LEAKED FORM THE BAG CONTAINING THE HAZARDOUS DRUG.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14874818 ↗
  • MalfunctionJun 21, 2022Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD ALARIS TEXIUM SECONDARY SET EXPERIENCED LEAKAGE WHICH LEAD TO PATIENT NOT RECEIVING THE ENTIRE DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY DRIPPING FROM BETWEEN THE MALE LEUR AND THE TEXIUM END. THIS RESULTED IN A CHEMO SPILL AND PATIENT DID NOT RECEIVE THE ENTIRE DOSE OF THE MEDICATION - OXALIPLATIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14758548 ↗
  • MalfunctionJan 10, 2022Material Separation; Material Separation

    IT WAS REPORTED 2 BD ALARIS TEXIUM SECONDARY SETS HAD COMPONENT SEPARATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CAME APART BELOW DRIP CHAMBER."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13204601 ↗
  • MalfunctionDec 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT 2 BD ALARIS TEXIUM SECONDARY SETS HAD COMPONENTS SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY CUSTOMER THAT THE TUBING CAME APART DURING PRIMING."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13053405 ↗
  • MalfunctionDec 21, 2021Material Separation; Material Separation

    IT WAS REPORTED THAT THE BD ALARIS¿ TEXIUM¿ SECONDARY SET CAME APART WHILE PRIMING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAME APART DURING PRIMING¿.NO FLUID, NO ADVERSE EVENT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13052376 ↗
  • MalfunctionDec 10, 2021Separation Failure; Separation Problem; Separation Failure; Separation Problem

    IT WAS REPORTED 2 BD SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED SEPARATION WITH NO LEAKAGE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEPARATION OTHER COMPONENT- NO LEAK, WHEN TUBING REMOVED FROM PACKAGE IT WAS REPORTED THAT THE TUBING CAME APART WHEN REMOVING TUBING FROM PACKAGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12980256 ↗
  • MalfunctionDec 10, 2021Material Separation; Material Separation

    IT WAS REPORTED THAT THE BD ALARIS TEXIUM SECONDARY SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12978287 ↗
  • MalfunctionDec 8, 2021Separation Failure; Separation Problem; Separation Failure; Separation Problem

    IT WAS REPORTED THAT BD ALARIS TEXIUM SECONDARY SET HAD COMPONENTS SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE TUBING CAME APART WHEN REMOVING TUBING FROM PACKAGES. "

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12960055 ↗
  • MalfunctionDec 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT BD ALARIS TEXIUM SECONDARY SET HAD COMPONENTS SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBING CAME APART BELOW THE DRIP CHAMBER"

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12923532 ↗
  • MalfunctionDec 2, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

    IT WAS REPORTED THAT 2 BD ALARIS TEXIUM SECONDARY SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12916287 ↗
  • MalfunctionDec 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BD ALARIS TEXIUM SECONDARY SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12914610 ↗
  • MalfunctionNov 22, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

    IT WAS REPORTED THAT THE BD ALARIS¿ TEXIUM¿ SECONDARY SET TUBING SEPARATED FROM BELOW THE DRIP CHAMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CAME APART BELOW DRIP CHAMBER".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12853538 ↗
  • MalfunctionNov 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BD SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12837666 ↗
  • MalfunctionNov 18, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER DURING USE. TUBING IS CONTAMINATED WITH BENDAMUSTINE CYTOTOXIC.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12837628 ↗
  • MalfunctionNov 18, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BD SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CAME APART BELOW DRIP CHAMBER DURING PRIMING OF TUBING. FLUID IN TUBING IS NS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12837225 ↗
  • MalfunctionNov 18, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE BS SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER. PATIENT INJURY: NO. QTY AFFECTED: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12837165 ↗
  • MalfunctionOct 14, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT 2 SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CAME APART BELOW DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12636153 ↗
  • MalfunctionOct 14, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED SEC 20DP, TEXIUM & HANGER V/NV HAD AN ISSUE WITH COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CAME APART BELOW DRIP CHAMBER."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12631375 ↗
  • MalfunctionOct 13, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED SEC 20DP, TEXIUM & HANGER V/NV HAD AND ISSUE WITH COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CAME APART BELOW DRIP CHAMBER".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12624675 ↗
  • MalfunctionOct 7, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TEXIUM SECONDARY SETS CAME APART BELOW THE DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12595021 ↗
  • MalfunctionOct 6, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THE SEC 20DP, TEXIUM & HANGER V/NV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE ALL THE 40000-07T TEXIUM SECONDARY SETS THAT CAME APART BELOW THE DRIP CHAMBER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12580885 ↗
  • MalfunctionOct 5, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED SEC 20DP, TEXIUM & HANGER V/NV SUFFERED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...TEXIUM SECONDARY SETS THAT CAME APART BELOW THE DRIP CHAMBER."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12579483 ↗
  • MalfunctionSep 28, 2021Material Separation; Material Separation

    IT WAS REPORTED TWO SEC 20DP, TEXIUM & HANGER V/NV HAD COMPONENT SEPARATION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 2 MORE TEXIUM SECONDARY SETS THAT CAME APART LIKE THE OTHERS."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12541658 ↗
  • MalfunctionSep 10, 2021Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT SEC 20DP, TEXIUM & HANGER V/NV LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT THERE IS LEAKAGE UNDER THE DRIP CHAMBER."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12456517 ↗

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.