BD Texium MY8010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403221675), received between Jun 25, 2019 and Jan 27, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD TEXIUM¿ NEEDLE-FREE SYRINGE WAS BLOCKED WHEN ATTACHED TO THE SPINAL NEEDLE. THREE ATTEMPTS WERE MADE TO INJECT WITHOUT SUCCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT WAS SEDATED FOR LUMBAR PUNCTURE WITH INTRATHECAL CHEMOTHERAPY. LUMBAR PUNCTURE AND CSF COLLECTION COMPLETED WITHOUT PROBLEM, ATTEMPTED TO ATTACH IT CHEMO SYRINGE TO HUB OF SPINAL NEEDLE, SOME FLASH OF YELLOW METHOTREXATE FLUID NOTED, BUT ONCE FULLY ATTACHED, COULD NOT INFUSE CHEMO, PLUNGER WOULD NOT BUDGE. REMOVED, READJUSTED, AND RE-ATTACHED, STILL WOULD NOT INFUSE. REMOVED AGAIN, SPINAL NEEDLE INSPECTED BY ATTENDING AND CSF NOTED TO STILL BE FREELY FLOWING. THIRD ATTEMPT ALSO UNSUCCESSFUL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251613 ↗
• MalfunctionJan 10, 2023Failure to Infuse

  PATIENT WAS SEDATED FOR LUMBAR PUNCTURE WITH INTRATHECAL CHEMOTHERAPY. LUMBAR PUNCTURE AND CSF COLLECTION COMPLETED WITHOUT PROBLEM, ATTEMPTED TO ATTACH IT CHEMO SYRINGE TO HUB OF SPINAL NEEDLE, SOME FLASH OF YELLOW METHOTREXATE FLUID NOTED, BUT ONCE FULLY ATTACHED, COULD NOT INFUSE CHEMO, PLUNGER WOULD NOT BUDGE. REMOVED, READJUSTED, AND RE-ATTACHED, STILL WOULD NOT INFUSE. REMOVED AGAIN, SPINAL NEEDLE INSPECTED BY ATTENDING AND CSF NOTED TO STILL BE FREELY FLOWING. THIRD ATTEMPT ALSO UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 16130590 ↗
• MalfunctionDec 22, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD TEXIUM¿ NEEDLE-FREE SYRINGE WAS FOUND BLOCKED WHEN CONNECTED TO THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A 10 ML TEXIUM SYRINGE FAILED TO OPEN FLUID PATCH WHEN ENGAGED WITH A NEEDLE. PROCEDURE HAD TO BE HALTED A NEW SYRINGE NEEDED TO BE MADE. RESULTED IN A 1-HOUR DELAY IN PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035574 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TEXIUM SYRINGE HAD MAJOR EMPLOYEE SAFETY AND PATIENT SAFETY CONCERNS. ETOPOSIDE RESIDUE WAS FOUND ON THE SMARTSITE OF THE 20MM VIALSHIELD AFTER DRAWING UP DRUG, AND DISCONNECTING THE TEXIUM BONDED SYRINGE FROM THE VIALSHIELD. SYRINGE TIP WAS WIPED WITH AN ALCOHOL SWAB TO REMOVE RESIDUE. ETOPOSIDE RESIDUE WAS FOUND ON THE SMARTSITE BAG ACCESS OF THE TEXIUM INFUSION SET AFTER INJECTING ETOPOSIDE 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 9288170 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TEXIUM SYRINGE HAD MAJOR EMPLOYEE SAFETY AND PATIENT SAFETY CONCERNS. ETOPOSIDE RESIDUE WAS FOUND ON THE SMARTSITE OF THE 20MM VIALSHIELD AFTER DRAWING UP DRUG, AND DISCONNECTING THE TEXIUM BONDED SYRINGE FROM THE VIALSHIELD. THE SYRINGE TIP WAS WIPED WITH AN ALCOHOL SWAB TO REMOVE RESIDUE. ETOPOSIDE RESIDUE WAS FOUND ON THE SMARTSITE BAG ACCESS OF THE TEXIUM INFUSION SET AFTER INJECTING ETOPOSIDE 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 9287721 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TEXIUM SYRINGE HAD MAJOR EMPLOYEE SAFETY AND PATIENT SAFETY CONCERNS. ETOPOSIDE RESIDUE WAS FOUND ON THE SMARTSITES OF THE 13MM VIAL ACCESS DEVICES AFTER DRAWING UP THE DRUG, AND DISCONNECTING THE TEXIUM BONDED SYRINGE FROM THE DEVICES. RESIDUE WAS WIPED OFF THE SYRINGE TIP WITH AN ALCOHOL PAD PRIOR TO INJECTING INTO THE BAG. ETOPOSIDE RESIDUE WAS FOUND ON THE SMARTSITE BAG ACCESS OF THE TEXIUM INFUSION SET AFTER INJECTING ETOPOSIDE 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 9287634 ↗
• 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 8733147 ↗