BD VersaSafe 11610341Recalls & reported problems
BD Switzerland Sàrl · Secondary Set, Needle-Free Valve Bag Access Port Nonvented Hanger 79 cm (31 in) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403221842), received between Sep 21, 2023 and Nov 10, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 reports).
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
Most reported problems
Device problems
- Leak/Splash6
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD TEXIUM EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE TEXIUM TIP OF THE SECONDARY TUBING STARTING TO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513668 ↗MalfunctionOct 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKING FROM THE TEXIUM CLOSED MALE LEUR CAP THAT WAS CONNECTED TO THE SECONDARY TUBING OF SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23347791 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. IT WAS REPORTED THAT BD SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT A COUPLE DROPS OF LIQUID ON THE FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334005 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SECONDARY SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE WHILE DOXIL WAS INFUSING PT NOTICED THERE WAS DOXIL LEAKING ON TOP OF THE PUMP AND SOME ON THE FLOOR. THE LEAK OCCURED AT THE Y SITE BY THE TEXIUM HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334000 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SECONDARY SET WAS LEAKING . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED THERE WERE 5-6 DROPS ON THE FLOOR AND THERE WAS LEAKAGE AROUND THE TEXIUM THAT WAS CONNECTED TO THE PRIMARY TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333973 ↗MalfunctionOct 19, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY WENT TO DISCONNECT PATIENT FROM INFUSION AND NOTICED SOME LIQUID ON THE FLOOR. DETERMINED IT WAS THE BENDEKA CHEMOTHERAPY INFUSION THAT WAS LEAKING FROM THE SECONDARY TUBING AT THE TEXIUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333971 ↗MalfunctionSep 21, 2023Material Separation; Material Separation
NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: 11610341, BATCH #: 22119220. IT WAS REPORTED BY CUSTOMER THAT THE SECONDARY TUBING FELL APART WHEN TRYING TO SPIKE CHEMOTHERAPY BAG. VERBATIM: RCC RECEIVED THE COMPLAINT VIA EMAIL. EMAIL AS ATTACHED. SECONDARY TUBING FELL APART WHEN TRYING TO SPIKE CHEMOTHERAPY BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17794229 ↗
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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
- 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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