Safsite® 415067Recalls & reported problems
B. Braun Medical Inc. · RV1000 REFLUX VALVE & CAP · Class 2
All models of Safsite (7)
Data updated Oct 18, 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 04022495769855), received between May 22, 2019 and Mar 13, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak4
- Leak/Splash3
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BLOOD SQUIRTING FROM VALVE WHEN HOOKED UP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599288 ↗MalfunctionOct 13, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BLOOD SPRAYING OUT OF CONNECTOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17929685 ↗MalfunctionOct 7, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE VALVE LEAKED BLOOD DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12589662 ↗MalfunctionJun 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE ANTI REFLUX VALVE DISCONNECTS FROM SPIROS AT THE PATIENTS IV SITE. END USER IS USING A FILTERED EXTENSION AND OUR REFLUX VALVE WHICH IS ATTACHED TO A SPIROS. THE SPIROS OFTEN DISCONNECTS FROM THE ANTI REFLUX VALVE WHICH IT SHOULD LOCK ON. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8714482 ↗MalfunctionMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: BLOOD LEAKAGE WAS OBSERVED WHEN DISCONNECTING THE SYRINGE AFTER ADMINISTRATION. "WE ARE ATTACHING THE SAFE SITE TO THE HUB OF CATHETER AND CONNECTING A 3 CC SYRINGE (TO DRAWN OUT BLOOD FOR CREATININE), THEN CONNECTING EXTENSION TUBING TO THE SAFE SITE. IT IS LEAKING BLOOD AFTER THE 3CC SYRINGE IS BEING DISCONNECTED." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8631250 ↗MalfunctionMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: BLOOD LEAKAGE WAS OBSERVED WHEN DISCONNECTING THE SYRINGE AFTER ADMINISTRATION. "WE ARE ATTACHING THE SAFE SITE TO THE HUB OF CATHETER AND CONNECTING A 3 CC SYRINGE (TO DRAWN OUT BLOOD FOR CREATININE), THEN CONNECTING EXTENSION TUBING TO THE SAFE SITE. IT IS LEAKING BLOOD AFTER THE 3CC SYRINGE IS BEING DISCONNECTED." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8631249 ↗MalfunctionMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: BLOOD LEAKAGE WAS OBSERVED WHEN DISCONNECTING THE SYRINGE AFTER ADMINISTRATION. "WE ARE ATTACHING THE SAFE SITE TO THE HUB OF CATHETER AND CONNECTING A 3 CC SYRINGE (TO DRAWN OUT BLOOD FOR CREATININE), THEN CONNECTING EXTENSION TUBING TO THE SAFE SITE. IT IS LEAKING BLOOD AFTER THE 3CC SYRINGE IS BEING DISCONNECTED." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8631248 ↗
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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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