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BD Texium MY8005Recalls & reported problems

BD Switzerland Sàrl · 5 mL Needle-Free Syringe · Class 2

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403221668), received between Jun 10, 2020 and Jun 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Device problems

  • Fluid/Blood Leak1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 10, 2020Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

    IT WAS REPORTED BY A BD ASSOCIATE THAT WHILE SEARCHING FOR INFORMATION ON TEXIUM, A YOUTUBE VIDEO WAS SEEN WHEREIN THE USER WAS DEMONSTRATING USE OF NEEDLE-FREE SYRINGE WITH BONDED TEXIUM CLOSED MALE LUER. IN THE VIDEO, IT WAS DEPICTED THAT STERILE WATER WAS ASPIRATED FROM A VIAL USING A NEEDLE ATTACHED TO THE PRODUCT. THE NEEDLE WAS THEN REMOVED. A LEAK WAS OBSERVED AS THE USER WAS PUSHING THE FLUID INTO TO THE NEEDLELESS CONNECTOR OF A PRIMARY TUBING WHILE TEXIUM MALE LUER IS PARTIALLY CONNECTED. THERE WAS NO PATIENT INVOLVEMENT .

    Patient problems: No Patient Involvement

    MAUDE report 10138966 ↗

Other Syringe, piston devices

All Syringe, piston devices →

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