BD Texium MY8020Recalls & reported problems
BD Switzerland Sàrl · 20 mL Needle-Free Syringe · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the BD Texium MY8020, a 20 mL needle-free syringe for transferring drugs without a needle. Most of the 31 reports describe fluid leaking or splashing out at the connection point during compounding or IV push administration, plus a few loose connections and one break. No deaths and no injuries. One open recall, started in May 2025, concerns leaking at the connector interface, which can delay procedures, interrupt treatment, or expose staff to hazardous drugs.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10885403221682), received between Jan 23, 2019 and Mar 26, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (25 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.
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 · FDA record ↗
Most reported problems
Device problems
- Leak/Splash25
- Fluid/Blood Leak4
- Contamination /Decontamination Problem2
- Loose or Intermittent Connection2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient5
- Insufficient Information3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702423 ↗MalfunctionMar 26, 2026Leak/Splash; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702405 ↗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: 20 ML TEXIUM LEAKED ON TECH WHEN COMPOUNDING. NOT PT INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468469 ↗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 23468135 ↗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: IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE IS LEAKING AT THE BONDING SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333661 ↗MalfunctionMar 11, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21580198 ↗MalfunctionJan 16, 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 DAUNORUBICIN WAS NOTED TO BE LEAKING AT THE Y-SITE FROM THE TEXIUM CAP DURING IV PUSH ADMINISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21175756 ↗MalfunctionJan 16, 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 DURING ADMINISTRATION OF PHESGO SUBCUTANEOUS (SQ), MULTIPLE DRIPS OF MEDICATION LEAKED FROM THE TEXIUM CONNECTION SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172523 ↗MalfunctionJan 14, 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 WHILE ADMINISTERING PHESGO SQ VIA BUTTERFLY NEEDLE. MEDICATION LEAKED AT CONNECTION OF TEXIUM CAP AND BUTTERFLY HUB. DRIPPED ONTO ABSORBENT PAD AND DID NOT REACH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21150288 ↗MalfunctionJan 7, 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 NURSE NOTIFIED PHARMACY THAT WHEN ADMINISTERING PHESGO, THE TEXIUM TIP STARTED TO LEAK. THE AMOUNT OF DRUG LOST WAS NOT SIGNIFICANT BUT THERE WAS VISIBLE LEAKING AT THE TEXIUM TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092174 ↗MalfunctionJan 3, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068785 ↗MalfunctionDec 26, 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 NURSE ADMINISTERING IV PUSH IDARUBICIN 25.3MG AT BEDSIDE. IDARUBICIN CAME IN SYRINGE WITH BONDED TEXIUM CLOSED SYSTEM TRANSFER DEVICE. PER PROTOCOL, NURSE ADDED PRIMARY LINE OF NORMAL SALINE AND ADDED TEXIUM TO DISTAL END OF PRIMARY TUBING AND ATTACHED TO PATIENT'S CENTRAL LINE. IDARUBICIN PUSHED AT LOWER Y OF PRIMARY TUBING. ABOUT 10 MINUTES INTO PUSH WITH 13.5ML REMAINING, NURSE NOTICED LEAKAGE FROM TEXIUM AT SYRINGE. INFUSION STOPPED; NURSE NOTICED A DRIP ON PATIENT'S SKIN. CLEANSED WITH SOAP AND WATER. ALSO, WHEN NURSE WENT TO DISCONNECT PRIMARY TUBING FROM CENTRAL LINE, THERE WAS A DROP OF FLUID AT THE DISTAL END OF THE TEXIUM UPON DISCONNECTION. LEADERSHIP AND PHARMACY NOTIFIED. NURSE TRANSPORTED CHEMO AND TUBING IN DOUBLE CHEMO BAG BACK TO PHARMACY TO OBTAIN NEW SYRINGE. ITEM # (B) (4) NOTE: RETURN TO MANUFACTURER HAS BEEN REQUESTED AND THIS IS IN PROCESS. RECURRENT ISSUES NOTED WITH TEXIUM. LEAKING FOR SIZE 50 WITH LOTS 24055854, ALSO LEAKED WHEN SHOOTING INTO IV BAG. LEAKING FOR SIZE 3
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21022123 ↗MalfunctionDec 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
MATERIAL: MY8020; BATCH#: 24035566. IT WAS REPORTED BY THE CUSTOMER THAT CONTAMINATION IN NECK OF SYRINGE OF THIS ¿STERILE¿ PRODUCT VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EVENT NUMBER 8: DATE OF EVENT: UNSURE. MATERIAL / LOT # MY8020 LOT 24035566. PATIENT HARM, INJURY, COMPLICATION, NEGATIVE OUTCOME CONTAMINATION IN NECK OF SYRINGE OF THIS ¿STERILE¿ PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20873769 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
MATERIAL # MY8020, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PATIENT RECEIVING DOXORUBICIN IV PUSH. WHEN ON THE LAST 5 ML MEDICATION STARTED DRIPPING FROM THE Y SITE. RN TIGHTENED SYRINGE TO Y-SITE CONNECTER IN CASE IT WAS LOOSE, BUT IT MADE IT WORSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20865216 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864009 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
MATERIAL # MY8020, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT WHEN ADMINISTERING ADRIAMYCIN, TWO SEPARATE SYRINGES BEGAN LEAKING MEDICATION. AT THE TEXIUM BONDING SITE RESULTING IN 3-4ML OF MEDICATION NOT ADMINISTERED TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863974 ↗MalfunctionDec 6, 2024Leak/Splash; Leak/Splash
MATERIAL#: MY8020, BATCH#: 24055856. IT WAS REPORTED BY CUSTOMER THAT WHILE RN WAS PUSHING SQ INJECTION THE CONNECTION BETWEEN THE CHEMO CAP AND NEEDLE (25G 5/8") WAS SHOWING NOTICEABLE LEAKING (APPROXIMATELY 4 DROPS). RCC RECEIVED A COMPLAINT VIA EMAIL. BELOW IS A SUMMARY OF RECENT SAFETY EVENTS REPORTED AT OUR CANCER CENTERS. THERE HAVE BEEN SEVERAL EVENTS INVOLVING BD TEXIUM TUBING AND SYRINGES WHERE NURSES AND PATIENTS HAVE BEEN AT RISK FOR EXPOSURE TO HAZARDOUS DRUG DUE TO LEAKING PRODUCTS. WE HAVE BEEN IN CONTACT WITH BD BUT HAVE NOT YET FOUND A RESOLUTION TO THIS ISSUE. WE ARE REPORTING TO THE FDA FOR AWARENESS IN CASE OTHER FACILITIES ARE ALSO SEEING THIS ISSUE. DATE, INTERNAL REFERENCE NUMBER, PRODUCT, LOT/EXP, EVENT. DESCRIPTION: 9/18/2024: (B)(6), MY8020/MY8030 BD 20ML AND 30ML TEXIUM SYRINGE, PATIENT RECEIVING DOXORUBICIN IV PUSH. WHEN ON THE LAST 5 ML MEDICATION STARTED DRIPPING FROM THE Y SITE. RN TIGHTENED SYRINGE TO Y-SITE CONNECTER IN CASE IT WAS LOOSE, BUT IT MADE IT WORSE. (20 ML AND 30 ML SYRINGES) ON (B)(6) 202024. (B)(6): MY8020 BD 20 ML TEXIUM SYRINGE, LOT: 24055856 / EXP NOT AVAILABLE - WHILE RN WAS PUSHING SQ. INJECTION THE CONNECTION BETWEEN THE CHEMO CAP
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863631 ↗MalfunctionDec 5, 2024Leak/Splash; Leak/Splash
MATERIAL: MY8020; BATCH#: 24055856. IT WAS REPORTED BY THE CUSTOMER THAT WHILE RN (REGISTERED NURSE) WAS PUSHING SQ (SUBCUTANEOUS) INJECTION THE CONNECTION BETWEEN THE CHEMO CAP AND NEEDLE (25G 5/8") WAS SHOWING NOTICEABLE LEAKING (APPROXIMATELY 4 DROPS). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHILE RN (REGISTERED NURSE) WAS PUSHING SQ (SUBCUTANEOUS) INJECTION THE CONNECTION BETWEEN THE CHEMO CAP AND NEEDLE (25G 5/8") WAS SHOWING NOTICEABLE LEAKING (APPROXIMATELY 4 DROPS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20853385 ↗MalfunctionDec 4, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849751 ↗MalfunctionDec 4, 2024Leak/Splash; Leak/Splash
MATERIAL: MY8020. LOT: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING WAS LEAKING FROM THE TEXIUM WHEN ADRIAMYCIN PUSHED. RN TIGHTENED CONNECTION AND THERE WERE NO FURTHER ISSUES. VERBATIM: TUBING LEAKING FROM TEXIUM WHEN ADRIAMYCIN PUSHED, RN TIGHTENED CONNECTION AND THERE WERE NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844739 ↗MalfunctionDec 4, 2024Leak/Splash; Leak/Splash
MATERIAL: MY8020/ MY8030 LOT: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT WHILE ADMINISTERING PHESGO VIA BUTTERFLY NEEDLE, IT WAS NOTED THAT MEDICATION WAS DRIPPING FROM THE GREEN CAP. APPROXIMATELY 1 ML WAS LOST. VERBATIM: WHILE ADMINISTERING PHESGO VIA BUTTERFLY NEEDLE NOTED MEDICATION DRIPPING FROM GREEN CAP. APPROXIMATELY 1ML WAS LOST. CHEMO DID NOT COME IN CONTACT WITH PT'S SKIN OTHER THAN INJECTION SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844209 ↗MalfunctionDec 3, 2024Leak/Splash; Leak/Splash
MATERIAL #: MY8020 AND BATCH#: 24055856. IT WAS REPORTED BY CUSTOMER THAT EXPERIENCING 4 DIFFERENT LEAKS FROM THE BONDED PRODUCT- AS THE TEXIUM PIECE IS COMING OFF CAUSING LEAKS. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. EXPERIENCING 4 DIFFERENT LEAKS FROM THE BONDED PRODUCT- AS THE TEXIUM PIECE IS COMING OFF CAUSING LEAKS.
Patient problems: Insufficient Information
MAUDE report 20834437 ↗MalfunctionDec 3, 2024Leak/Splash; Leak/Splash
MATERIAL #: MY8020, BATCH#: 24055856. IT WAS REPORTED BY CUSTOMER THAT EXPERIENCING 4 DIFFERENT LEAKS FROM THE BONDED PRODUCT- AS THE TEXIUM PIECE IS COMING OFF CAUSING LEAKS. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. EXPERIENCING 4 DIFFERENT LEAKS FROM THE BONDED PRODUCT- AS THE TEXIUM PIECE IS COMING OFF CAUSING LEAKS.
Patient problems: Insufficient Information
MAUDE report 20834433 ↗MalfunctionDec 3, 2024Leak/Splash; Leak/Splash
MATERIAL #: MY8020. BATCH#: 24055856. IT WAS REPORTED BY CUSTOMER THAT EXPERIENCING 4 DIFFERENT LEAKS FROM THE BONDED PRODUCT- AS THE TEXIUM PIECE IS COMING OFF CAUSING LEAKS. COMPLAINT RECEIVED. EXPERIENCING 4 DIFFERENT LEAKS FROM THE BONDED PRODUCT- AS THE TEXIUM PIECE IS COMING OFF CAUSING LEAKS.
Patient problems: Insufficient Information
MAUDE report 20834418 ↗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: WHILE RN WAS PUSHING SQ PHESGO INJECTION THE CONNECTION BETWEEN THE CHEMO CAP AND NEEDLE WAS SHOWING NOTICEABLE LEAKING (APPROXIMATELY 4 DROPS). RN ATTEMPTED TO TIGHTEN THE NEEDLE MORE TO THE SYRINGE, BUT THE NEEDLE WAS ALREADY AS TIGHT AS IT WOULD GO. (20 ML SYRINGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20490196 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.