BD SmartSite C42014E-07Recalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve, 4 Needle-Free Valves, 4-Way Stopcock, Vented/Nonvented 297 cm (117 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613203020756), received between Jun 29, 2023 and Feb 19, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Defective Component” (3 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
- Defective Component3
- Connection Problem2
- Leak/Splash2
- Separation Problem2
- Complete Blockage1
- Degraded1
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information4
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Connection Problem
MalfunctionFeb 19, 2026Misconnection; Connection Problem
MalfunctionFeb 19, 2026Separation Problem
MalfunctionFeb 19, 2026Separation Problem
MalfunctionMar 3, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT HAD ANOTHER IV TUBING FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511424 ↗MalfunctionFeb 11, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAVE HAD ANOTHER IV TUBING FAILURE AND HAVE THE PRODUCT FOR YOU TO EVALUATE. PLEASE CONTACT ME AT YOUR EARLIEST CONVENIENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21353516 ↗MalfunctionOct 27, 2024Leak/Splash; Leak/Splash
MATERIAL #: C42014E-07 AND BATCH#: 24089111. IT WAS REPORTED BY CUSTOMER THAT WE HAD PRODUCT FAILURE ON THIS PRODUCT, LEAKAGE AT THE Y SITE LOT# (10)24089111). VERBATIM: COMPLAINT RECEIVED VIA EMAIL. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAD PRODUCT FAILURE ON THIS PRODUCT, LEAKAGE AT THE Y SITE LOT# (10)24089111). PRODUCT / CATALOGUE NUMBER - B-DC42014E07. LOT/SERIAL NUMBER - (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20540986 ↗MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20393062 ↗MalfunctionOct 3, 2023Degraded; Degraded
NO ADDITIONAL INFORMATION. MATERIAL #: C42014E-07, BATCH #: 23079266. IT WAS REPORTED BY CUSTOMER THAT WHEN TUBING WAS OPENED IT WAS NOTED THAT THE CLAMP WAS NOT PLACED CORRECTLY ON TUBING MAKING IT NOT FUNCTIONAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN TUBING WAS OPENED IT WAS NOTED THAT THE CLAMP WAS NOT PLACED CORRECTLY ON TUBING MAKING IT NOT FUNCTIONAL. XXX HAS PRODUCT SAVED AT THE SITE FOR INVESTIGATION, IF NEEDED. RESPONSE RECEIVED 25 SEP 2023. HOW MANY OCCURRENCES OF THE DEFECTIVE SET(S)? ONLY 1 SET AT THIS TIME. KINDLY CONFIRM WHETHER OR NOT THERE WAS PATIENT INVOLVEMENT. DEFECTIVE CLAMP WAS FOUND BEFORE IT REACHED THE PATIENT. ADDT RESPONSE RECEIVED 26 SEP 2023. THE LOT NUMBER IS (10)23079266. PRODUCT WILL BE GOING OUT TODAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861251 ↗MalfunctionJun 29, 2023Defective Component; Defective Component
IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ SMARTSITE¿ GRAVITY SET THE TUBING BROKE OFF AT THE PORT. THIS IS 2 OF 2 MALFUNCTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT COMPLAINT INVOLVING BD SMART SITE GRAVITY TUBING BREAKING OFF AT THE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17234712 ↗MalfunctionJun 29, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING USE WITH 2 BD ALARIS¿ SMARTSITE¿ GRAVITY SET THE DEVICES WERE CLOGGED. THIS IS 1 OF 2 MALFUNCTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT COMPLAINT INVOLVING BD SMART SITE GRAVITY TUBING NOT BEING ABLE TO BE PRIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17234708 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page