BD SmartSite 11059728Recalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve, 4-Way Stopcock, 4 Needle-Free Valves, Vented/Nonvented 259 cm (102 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885403234644), received between Apr 5, 2019 and Dec 4, 2019 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak9
- Disconnection8
- Crack4
- Obstruction of Flow4
- Free or Unrestricted Flow2
- Appropriate Device Problem Term/Code Not Available1
- Backflow1
- Fracture1
Patient problems
- No Information11
- No Consequences Or Impact To Patient6
- Blood Loss2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2019Backflow; Disconnection; Backflow; Disconnection
IT WAS REPORTED THAT THE ANESTHESIOLOGIST REMOVED THE GRAVITY TUBING SET FROM THE PACKAGE AND TIGHTENED ALL OF THE CONNECTIONS PRIOR TO ATTACHING TO THE PATIENT. DURING THE INDUCTION PROCEDURE, THE ANESTHESIOLOGIST NOTED THAT THE TUBING SET UNINTENTIONALLY DISCONNECTED AND LEAKED APPROXIMATELY 20ML OF THE PATIENT'S BLOOD. IT WAS FURTHER STATED THAT WHEN THE ANESTHESIOLOGIST TIGHTENS THE TUBING SETS FIXED MALE LUER TO PREVENT FURTHER UNINTENTIONAL DISCONNECTS, THE MALE LUER CRACKED.
Patient problems: Blood Loss
MAUDE report 9414251 ↗MalfunctionOct 11, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT PRIOR TO THE PATIENT BEING INDUCED, THE RN NOTICED THAT FLUID WAS LEAKING FROM THE TUBING. THE TUBING WAS FRACTURED. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9178775 ↗MalfunctionOct 8, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE TUBING ON A STANDARD CASE BECAME DETACHED AND FLUID AND BLOOD LEAKED TO THE FLOOR. THE PATIENT DID NOT RECEIVE THE REQUIRED FLUID OR MEDICATION THAT WAS NEEDED AT THE TIME.
Patient problems: No Information
MAUDE report 9166240 ↗MalfunctionAug 14, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT TUBING CAME APART AT THE CONNECTION AND LEAKED WHEN THE PATIENT WAS REPOSITIONING. THERE WAS AN UNKNOWN AMOUNT OF MEDICATION GIVEN ¿ SMALL AMOUNT OF BLOOD LOSS: HIGH RISK OF BLOOD LOSS AND HIGH RISK OF INFECTION. "TUBING WAS DISPOSED OF DUE TO THE LEVEL OF CONTAMINATE."
Patient problems: Blood Loss
MAUDE report 8894812 ↗MalfunctionJul 29, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD IT CAUSED A CRACK IN THE HUB AND LEAKED.
Patient problems: No Information
MAUDE report 8838108 ↗MalfunctionJul 29, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD IT CAUSED A CRACK IN THE HUB AND LEAKED. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8836994 ↗MalfunctionJul 29, 2019Obstruction of Flow; Free or Unrestricted Flow; Obstruction of Flow; Free or Unrestricted Flow
IT WAS REPORTED WHEN INITIATING A FLUID FOR ADMINISTRATION THE USER NOTICED THAT THERE WAS NO FLOW WITH THE ROLLER CLAMP ACTIVATED . UPON CLOSER OBSERVATION THERE WAS A KINK IN THE SET. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8836923 ↗MalfunctionJul 25, 2019Obstruction of Flow; Free or Unrestricted Flow; Obstruction of Flow; Free or Unrestricted Flow
IT WAS REPORTED THAT WHEN THE TUBING WAS TAPED IN PLACE, THE USER NOTICED A BEND CAUSING A KINK IN THE SET WITH NO FLOW. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8826406 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD THE CONNECTION BECAME LOOSE. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8824928 ↗MalfunctionJul 24, 2019Loose or Intermittent Connection
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD THE CONNECTION BECAME LOOSE. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8824916 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD THE CONNECTION BECAME LOOSE. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8824910 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD THE CONNECTION BECAME LOOSE. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL EVENT DETAILS/PRODUCT INFORMATION PROVIDED.
Patient problems: No Information
MAUDE report 8824907 ↗MalfunctionJul 24, 2019Disconnection; Disconnection
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT THE CONNECTION BECOME LOOSE AFTER TIGHTENING THE HUB.
Patient problems: No Information
MAUDE report 8824896 ↗MalfunctionJul 24, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT WHEN TIGHTENING THE CONNECTION ON A GRAVITY SET WITH STOPCOCKS-MANIFOLD IT CAUSED A CRACK IN THE HUB AND LEAKED.
Patient problems: No Information
MAUDE report 8824846 ↗MalfunctionJul 24, 2019Disconnection; Fluid/Blood Leak; Insufficient Device Problem Information; Disconnection; Fluid/Blood Leak; Insufficient Device Problem Information
IT WAS REPORTED THE TUBING, A GRAVITY SET WITH STOPCOCKS-MANIFOLD WAS USED FOR A PATIENT BEING PREP FOR ANESTHESIA. AFTER CONFIRMING THE STOPCOCKS WERE SECURE AND THE LINE WAS FASTENED, THE USER NOTICED THAT THE TUBING DISCONNECTED FROM THE MANIFOLD AND LEAKED. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8824176 ↗MalfunctionJul 9, 2019Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED FROM THE ANESTHESIA DEPARTMENT, PACU AND ASU THAT THE ROLLER CLAMP COMPRESSES THE TUBING TO THE POINT THAT NO FLUID IS ABLE TO MOVE THROUGH THE AREA-IT IS ALSO HIDDEN BY THE ROLLER. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8773436 ↗MalfunctionJul 9, 2019Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED FROM THE ANESTHESIA DEPARTMENT, PACU AND ASU THAT THERE HAS ALSO BEEN MULTIPLE TIMES WHERE THE TUBING FOLDS OVER ITSELF AND CLAMPS THE TUBING OFF. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8773432 ↗MalfunctionJul 9, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED FROM THE ANESTHESIA DEPARTMENT, PACU AND ASU THAT THE CONNECTOR HUB WHEN TIGHTENED CRACKED AND LEAKED BLOOD. THE CONNECTION THUS CAUSING THREE ISSUES, POSSIBLE FOREIGN BODY, POSSIBLE INFECTION, INADEQUATE TRANSFER OF FLUIDS AND MEDICATIONS TO PATIENT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8773165 ↗MalfunctionJul 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED FROM THE ANESTHESIA DEPARTMENT, PACU AND ASU THAT THE CONNECTOR HUB WHEN TIGHTENED DOES NOT MAINTAIN A SNUG FIT. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8772748 ↗MalfunctionApr 5, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING DISCONNECTED AND LEAKED CAUSING THE PATIENT TO BLEED. THERE WAS NO REPORT OF HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8489471 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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