BD Texium MY8003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403221651), received between Jun 25, 2019 and Jan 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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-1971-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Leak/Splash; Leak/Splash

  MATERIAL #:MY8003, BATCH#:24036107. IT WAS REPORTED THAT THE BD TEXIUM NEEDLE-FREE SYRINGE, 3 ML WAS LOOSE RESULTING IN LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PATIENT WAS RECEIVING VELCADE INJECTION. TOWARDS THE END OF THE INJECTION ABOUT 3 DROPS OF MEDICATION CAME FROM THE TEXIUM CAP, BETWEEN THE CAP AND THE NEEDLE CONNECTION. NEEDLE WOULD NOT SCREW ON ANY TIGHTER AND WAS ON STRAIGHT. ITEM -MY8003, LOT -24036107.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118703 ↗
• MalfunctionAug 4, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TEXIUM NEEDLE-FREE SYRINGE, 3 ML LEAKED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MY8003-0006 BATCH NO (LOT NO): UNKNOWN. IT WAS REPORTED THE TEXIUM SYRINGE LEAKED WHILE GIVING AN INJECTION. I HAVE ONE NURSE WHO IS HAVING A PROBLEM WITH THE 3CC TEXIUM SYRINGE LEAKING EVERY TIME SHE INJECTS A S.C. DOSE OF VELCADE. ALL MY NURSES IN THE CLINIC HAVE A PROBLEM WITH THE DRUG WANTING TO SHOOT STRAIGHT OUT OF THE NEEDLE WHEN THEY ATTACH THE NEEDLE TO THE TEXIUM FOR INJECTION; HOWEVER THEY HAVE FOUND A WORKAROUND FOR THAT ISSUE SO I DON¿T BELIEVE I NEED HELP WITH THAT. THEY ARE HOLDING ONTO THE PLUNGER AND PULLING BACK AT THE SAME TIME THEY ATTACH THE NEEDLE AND THEREFORE PREVENTING THE DRUG FROM SQUIRTING OUT THE NEEDLE TOP. SO PROBLEM SOLVED ON THAT ISSUE. I DON¿T SEEM TO HAVE ANY LEAKS AT THE TEXIUM/NEEDLE SITE WITH ANY OTHER NURSE EXCEPT ONE ¿ AND SHE CONTINUES TO HAVE LEAKS DAY AFTER DAY. I DO NOT HAVE PRODUCT TO RETURN TO YOU NOR DO I HAVE THE EXACT LOT NUMBER. AS I STATED PREVIOUSLY; WE ARE USING THE CAREFUSION SYRINGE WITH A 25G S.C. SAFETY NEEDLE BY COVIDIEN FOR INJECTION OF VELCADE. I WAS MOSTLY LOOKING FOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361436 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TEXIUM SYRINGE HAD MAJOR EMPLOYEE SAFETY AND PATIENT SAFETY CONCERNS. VELCADE RESIDUE WAS FOUND ON THE SMARTSITE OF THE 13MM VIAL ACCESS DEVICE AFTER DRAWING UP DRUG, AND DISCONNECTING THE TEXIUM BONDED SYRINGE FROM THE DEVICE. THIS EVENT OCCURRED IN THE PHARMACY AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9288497 ↗
• MalfunctionOct 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK OCCURRED BETWEEN THE SYRINGE 3ML AND THE BONDED TEXIUM CONNECTOR DURING A VELCADE INJECTION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234433 ↗
• MalfunctionJun 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VISIBLE RESIDUE OF HAZARDOUS DRUGS ON CONNECTING SURFACES UPON DISCONNECTION WHEN THEY PREPARE CHEMO IN THEIR PHARMACY 90-100% OF THE TIME EVERY DAY FOR THE PAST 5 YEARS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733099 ↗