BD Texium MY8060Recalls & reported problems
BD Switzerland Sàrl · 50ml Needle-Free Syringe · Class 2
All models of BD Texium (7)
Data updated Oct 16, 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 Texium needle-free syringe has 94 reports, all describing malfunctions, with no deaths and no injuries. Common reports describe leaks during connection and parts breaking. The 1 open recall, from May 2025, concerns drug transfer devices that may leak at a connection, which can delay procedures and expose people to hazardous drugs. Reports fell from 32 in the prior 12 months to 15 in the latest 12 months.
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
- 94
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10885403221699), received between Jul 13, 2018 and Apr 22, 2026 — classified as 94 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (51 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 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-1971-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash51
- Fluid/Blood Leak23
- Break21
- Loose or Intermittent Connection7
- Complete Blockage1
- Defective Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Patient Involvement27
- No Consequences Or Impact To Patient16
- No Information5
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960554 ↗MalfunctionApr 22, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24960553 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693926 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURS DURING CONNECTION AND/OR WHILE PUSHING DRUG INTO THE BAG. STAFF REPORT THE CONNECTION MAY NOT THREAD CORRECTLY WITH THE BAG ACCESS DEVICE. NOTABLY, WHEN THE TEXIUM SYRINGE IS SECURED/TIGHTENED FULLY, LEAKAGE APPEARS MORE LIKELY, AND SLIGHTLY LOOSENING MAY REDUCE LEAKAGE. LEAKAGE HAS OCCURRED WITH BOTH 20 ML AND 50 ML SIZES AND ACROSS DIFFERENT LOTS. DESCRIBE PATIENT / HCP / USER IMPACT: HAZARDOUS DRUG EXPOSURE, CHEMO LEAK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693923 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693921 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURS DURING CONNECTION AND/OR WHILE PUSHING DRUG INTO THE BAG. STAFF REPORT THE CONNECTION MAY NOT THREAD CORRECTLY WITH THE BAG ACCESS DEVICE. NOTABLY, WHEN THE TEXIUM SYRINGE IS SECURED/TIGHTENED FULLY, LEAKAGE APPEARS MORE LIKELY, AND SLIGHTLY LOOSENING MAY REDUCE LEAKAGE. LEAKAGE HAS OCCURRED WITH BOTH 20 ML AND 50 ML SIZES AND ACROSS DIFFERENT LOTS. DESCRIBE PATIENT / HCP / USER IMPACT: HAZARDOUS DRUG EXPOSURE, CHEMO LEAK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693920 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693915 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693914 ↗MalfunctionMar 25, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24693913 ↗MalfunctionMar 19, 2026Complete Blockage
IT WAS REPORTED OCCLUSION WITH TEXIUM. ADDITIONAL INFORMATION. DELAY IN COMPOUNDING PROCESS, THIS SHORT TUBING SET WITH THE TEXIUM ACCESS WOULD NOT LET THE TECHNICIAN PUSH ANY DRUG THROUGH AND THEY HAD TO GET A NEW IV BAG AND TUBING SET TO FINISH THE PREP. NO PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641105 ↗MalfunctionJan 12, 2026Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT DURING COMPOUNDING OF CHEMOTHERAPY MEDICATION WITH A 50 ML TEXIUM BONDED SYRINGE, THE LIQUID LEAKED OUT OF THE TIP WHERE IT CONNECTED TO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24033149 ↗MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT ANOTHER LEAK OCCURRED WHEN INITIATING THE BLEOMYCIN. THE MEDICATION WAS HUNG ON THE IV POLE AND CONNECTED TO THE SECONDARY Y-SITE HUB. RN NOTED THE MEDICATION DRIPPED IN THE CHAMBER, BUT THE PUMP HAD NOT YET STARTED. CLEAR LIQUID NOTED ON THE TEXIUM CONNECTOR BETWEEN THE GREEN AND WHITE MOLDED AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23514201 ↗MalfunctionNov 6, 2025Leak/Splash; Leak/Splash
NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23488378 ↗MalfunctionNov 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKED WHILE MAKING A PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468646 ↗MalfunctionNov 3, 2025Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD 50ML TEXIUM SYRINGE MY8060 BROKE OFF AT BOND, RESULTING IN APPROX. 50ML FLUOROURACIL LOSS. LOT: 25017237 EXP: 01-21-2028.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459095 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLED FREE SYRINGE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD ANOTHER FAULTY 50ML TEXIUM SYRINGE.IT STARTED LEAKING WHEN I WAS ALMOST DONE INJECTING THE DRUG IN THE BAG
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334040 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE DOXORUBICIN WAS LEAKING FROM TEXIUM CONNECTION TO THE FLUSH LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334017 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT A LEAKING 50ML TEXIUM SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334016 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE ADRIAMYCIN BEGAN TO LEAK AT THE TOP OF THE TEXIUM THAT CONNECTS INTO THE PRIMARY TUBING. IV PUSH STOPPED; PHARMACY NOTIFIED AND WAS REMADE IN PHARMACY BEFORE RESTARTING IV PUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333998 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE DRUG LEAKED FROM THE CONNECTION BETWEEN THE 50ML. TEXIUM SYRINGE AND THE PORT ON THE PRIMARY TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333972 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE 50 ML TEXIUM LEAK LOT 25045705 OCCURRED IN PREPARATION TRANSFERRED TO A 30 ML SYRINGE AND THIS ALSO LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333964 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKED A LOT THROUGH THE TEXIUM PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333734 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKED A LOT THROUGH THE TEXIUM PIECE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333730 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AS DRUG WAS BEING ADDED TO AN IV BAG THROUGH THE SECONDARY TUBING PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333701 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333700 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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.
How reports and recalls are matched · Editorial policy · Report an error on this page