BD Texium MY8030Recalls & reported problems
BD Switzerland Sàrl · 30 mL 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 MY8030 is a 30 mL needle-free syringe used to transfer and inject drugs such as chemotherapy without a needle. The 30 reports mostly describe leaking or splashing at the connector, and sometimes fluid that would not draw up or push out. No deaths or injuries are reported. One recall, started in May 2025 and still open, covers leaking at the interface between the connector and the syringe, which can delay procedures or interrupt treatment.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10885403230523), received between Jun 25, 2019 and Dec 23, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (18 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/Splash18
- Fluid/Blood Leak7
- Complete Blockage2
- Contamination1
- Contamination /Decontamination Problem1
- Defective Component1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Patient Involvement4
- No Consequences Or Impact To Patient3
- No Information1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD TEXIUM NEEDLE FREE SYRINGE HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TECHNICIAN WENT TO DRAW FLUID OUT OF A COUPLE ELAHERE VIALS. THE FIRST VIAL WENT FINE AND SHE WAS ABLE TO DRAW THE FLUID OUT AS ANTICIPATED. WHEN SHE WENT TO THE NEXT VIAL, SHE WAS NOT ABLE TO DRAW BACK ANY LIQUID FROM THAT VIAL WITH THIS 30 ML SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876701 ↗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 30ML TEXIUM SYRINGE LEAK ON ME TODAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513829 ↗MalfunctionOct 30, 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: IT WAS REPORTED BY CUSTOMER THAT LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433353 ↗MalfunctionOct 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS TEXIUM NEEDLE FREE SYRINGE WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433351 ↗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 EXP 04/27/208 OCCURRED IN PREPARATION TRANSFERRED TO A 30 ML SYRING AND THIS ALSO LEAKED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333941 ↗MalfunctionApr 2, 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: "RN HAD DOXORUBICIN DOSE MADE UP OF 4 SEPARATE SYRINGES. ONE OF THE 20 ML SYRINGES LEAKED FROM TEXIUM ADAPTER PRIOR TO ADMINISTERING DOSE. RN RETURNED SYRINGE TO PHARMACY AND ANOTHER 20 ML SYRINGE WAS PREPPED AND DISPENSED. THE FINAL 20 ML SYRINGE WAS ADMINISTERED WITHOUT INCIDENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753508 ↗MalfunctionApr 2, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD TEXIUM NEEDLE-FREE SYRINGE HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED: "PHARMACY HAD TO DRAW UP NEW SYRINGES OF DOXORUBICIN (20 ML AND 20.7 ML) DUE TO PROBLEM WITH SYRINGES. ONE SYRINGE CONTAINING 20 ML OF DOSE WAS ADMINISTERED WITHOUT INCIDENT. RN STATED THAT THE TWO SYRINGES CONTAINING THE REST OF DOSE WOULD NOT PUSH. WHEN PULLING PLUNGER BACK TO SEE IF THERE WAS BLOOD RETURN, AIR ENTERED THE SYRINGE. ONE OF THE PLUNGERS IN SYRINGE MAY HAVE POPPED OUT OF SYRINGE CHAMBER (OR ALMOST POPPED OUT). PHARMACY PROVIDED NEW DOSES, AND THE REST OF DOSE WAS GIVEN WITH OUT SYRINGES MALFUNCTIONING. RN WILL BE SUBMITTING THEIR OWN SI WHICH WILL HAVE MORE DETAILS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21753395 ↗MalfunctionJan 16, 2025Leak/Splash; Leak/Splash
MATERIAL # MY8030, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE TEXIUM ATTACHMENT ON THE ADRIAMYCIN SYRINGE LEAKED DRUG WHILE PUSHING ADRIAMYCIN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE TEXIUM ATTACHMENT ON THE ADRIAMYCIN SYRINGE LEAKED DRUG WHILE PUSHING ADRIAMYCIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172522 ↗MalfunctionJan 13, 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 THE DRUG BEGAN TO LEAK FROM THE AREA WHERE THE TEXIUM TIP CONNECTS TO THE SYRINGE JUST AS THE NURSE STARTED INFUSING THE DOXORUBICIN VIA IV PUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138191 ↗MalfunctionJan 2, 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 NURSE REPORTED TO PHARMACY THAT 1 OF 4 DOXORUBICIN SYRINGES WITH TEXIUM WAS LEAKING DURING ADMINISTRATION TO PATIENT. NEARLY ENTIRE DOSE WAS ADMINISTERED TO PATIENT; HOWEVER SMALL AMOUNT OF DOXORUBICIN REMAINED IN THE TUBING WHICH LEAKED DURING FLUSHING. I
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21054742 ↗MalfunctionDec 26, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21022122 ↗MalfunctionDec 5, 2024Leak/Splash; Leak/Splash
MATERIAL: MY8030; BATCH#: 24066951. IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER'S CONCERN IS HIGH SINCE THIS CONTINUES TO HAPPEN. CUSTOMER'S CONCERN IS HIGH SINCE THIS CONTINUES TO HAPPEN ADDITIONAL INFORMATION: PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE EXACT ISSUE? ONE OF OUR 30 CC TEXIUM SYRINGES WAS LEAKING WHEN THE TECHNICIAN WAS USING NOT CONNECTED TO A SMART-SITE NEEDLE FREE VALVE. THE CHEMOTHERAPY WAS LEAKING FROM THE TEXIUM TIP, NOT THE BONDED PIECE ABOVE IT. MAKES ME QUESTION IF THE INTERNAL LEUR LOCK MECHANISM WAS SLIGHTLY OFF. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENTS OCCURRED WITH THE TECHNICIAN. HE DID HAVE TO CHANGE HIS GLOVES AFTER THE LEAK, BUT NO PERSONAL HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20855224 ↗MalfunctionDec 5, 2024Leak/Splash; Leak/Splash
MATERIALS: UNKNOWN BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT WHEN ADMINISTERING MEDICATION, TWO SEPARATE SYRINGES BEGAN LEAKING MEDICATION AT THE TEXIUM BONDING SITE RESULTING IN 3-4ML OF MEDICATION NOT ADMINISTERED TO PATIENT. THE LEAKAGE OCCURRED DURING IV PUSH ADMINISTRATION TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854912 ↗MalfunctionDec 4, 2024Leak/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 THERE WAS LEAKAGE FROM THE TEXIUM MALE LUER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849539 ↗MalfunctionDec 3, 2024Leak/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 PATIENT WAS RECEIVING ADRIAMYCIN VIA IVP. WHEN PUSHING THE LAST 1-2 ML OF THE MEDICATION, THERE WAS LEAKAGE BETWEEN THE TUBING AND THE TEXIUM CAP SITE THAT SHOULD BE GLUED/CONNECTED TOGETHER. MAY INVOLVE MY8020/MY8030 SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20839364 ↗MalfunctionDec 3, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM NEEDLE-FREE SYRINGE INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM DURING DOXORUBICIN INFUSION, THE Y-SITE WHERE THE SYRINGE IS CONNECTED TO THE PRIMARY TUBING WAS LEAKING WHEN THE MEDICATION WAS ADMINISTERED. 2 OUT OF 3 SYRINGES LEAKED AT THE Y-SITE. MAY INVOLVE MY8020/MY8030 SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20839359 ↗MalfunctionNov 19, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20723660 ↗MalfunctionNov 18, 2024Leak/Splash; Leak/Splash
INCORRECT GRID ENTRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707326 ↗MalfunctionNov 15, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20700733 ↗MalfunctionOct 20, 2024Leak/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 THE LAST 5 ML OF MEDICATION STARTED DRIPPING FROM THE Y SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490204 ↗MalfunctionOct 20, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490184 ↗MalfunctionMay 14, 2024Contamination; Contamination
MATERIAL # MY8030 LOT # 23115070 IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE 30ML CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A PHARMACY TECHNICIAN DISCOVERED A PARTICLE WITHIN THE BARREL AND PLUNGER PRIOR TO USING THE TEXIUM SYRINGE." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE ARE REPORTING A QUALITY ISSUE THAT OCCURRED YESTERDAY, 4/18/2024. ¿ TEXIUM 30 ML NEEDLE-FREE SYRINGE / CATALOG NUMBER MY8030 ¿ LOT NUMBER 23115070 ¿ ANY INJURIES AND/OR HARM? NO ¿ WHAT IS THE ISSUE YOU EXPERIENCED? A PHARMACY TECHNICIAN DISCOVERED A PARTICLE WITHIN THE BARREL AND PLUNGER PRIOR TO USING THE TEXIUM SYRINGE. ¿ IS THE ACTUAL SAMPLE OR SAMPLE REPRESENTATIVE AVAILABLE? (IF POSSIBLE, PLEASE SEND AFFECTED SAMPLE) YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19312088 ↗MalfunctionDec 20, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DOXORUBICIN LEAKED FROM THE BD TEXIUM¿ NEEDLE-FREE SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ONCOLOGY TECHNICIAN HAS BROUGHT TO MY ATTENTION THAT THE TEXIUM NEEDLE FREE SYRINGE IS EXPERIENCING SOME LEAKING/DRUG EXPOSURE WHEN USING. RECENTLY, DOXORUBICIN WAS USED... AND THE DRUG CAN CLEARLY BE SEEN (SINCE DRUG IS RED)"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16018741 ↗MalfunctionNov 12, 2019Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information
THE TEXIUM NEEDLE-FREE 30ML SYRINGE WAS RECEIVED WITH TWO SMARTSITE VIAL-SHIELD(S), AS AN UNEXPECTED RETURN, WITH UNSPECIFIED ISSUES AND NO INDICATION OF A FAILURE MODE. ALTHOUGH REQUESTED, THERE HAS BEEN NO FURTHER PATIENT OR EVENT INFORMATION MADE AVAILABLE TO DATE.
Patient problems: No Information; No Patient Involvement
MAUDE report 9310026 ↗MalfunctionNov 7, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A TEXIUM SYRINGE HAD MAJOR EMPLOYEE SAFETY AND PATIENT SAFETY CONCERNS. TECENTRIQ RESIDUE WAS FOUND ON THE SMARTSITE OF THE 20MM VIALSHIELD AFTER DRAWING UP DRUG, AND DISCONNECTING THE TEXIUM BONDED SYRINGE FROM THE VIALSHIELD. TECENTRIQ RESIDUE WAS FOUND ON THE SMARTSITE BAG ACCESS OF THE TEXIUM INFUSION SET AFTER INJECTING TECENTRIQ INTO THE SMARTSITE BAG ACCESS WITH THE TEXIUM BONDED SYRINGE. THIS EVENT OCCURRED IN THE PHARMACY AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9291570 ↗
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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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