SafeDAY™ 352905Recalls & reported problems
B. Braun Medical Inc. · SMBORE EXT W/SAFEDAY, MALE SPIN-LOCK, 8" · Class 2
All models of SafeDAY (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046955678129), received between Mar 16, 2023 and Oct 11, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2024Leak/Splash; Leak/Splash
AS REPORTED, EVENT 3 RECENTLY WE HAVE HAD AT LEAST THREE INSTANCES WHERE OUR J-LOOPS FOR IV'S, SAFEDAY EXTENSION SET REF 352905 LOT 0061938553 HAVE BEEN LEAKING FROM THE CONNECTION TO THE CLAVE. THESE EXTENSION SETS ARE SOMETIMES USED WITH PATIENTS WHO ARE RECEIVING CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427362 ↗MalfunctionOct 11, 2024Leak/Splash; Leak/Splash
AS REPORTED, EVENT 2: RECENTLY WE HAVE HAD AT LEAST THREE INSTANCES WHERE OUR J-LOOPS FOR IV'S, SAFEDAY EXTENSION SET REF 352905, LOT 0061938553 HAVE BEEN LEAKING FROM THE CONNECTION TO THE CLAVE. THESE EXTENSION SETS ARE SOMETIMES USED WITH PATIENTS WHO ARE RECEIVING CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427309 ↗MalfunctionOct 11, 2024Leak/Splash; Leak/Splash
AS REPORTED, EVENT 1: RECENTLY WE HAVE HAD AT LEAST THREE INSTANCES WHERE OUR J-LOOPS FOR IV'S, SAFEDAY EXTENSION SET REF 352905 LOT 0061938553 HAVE BEEN LEAKING FROM THE CONNECTION TO THE CLAVE. THESE EXTENSION SETS ARE SOMETIMES USED WITH PATIENTS WHO ARE RECEIVING CHEMOTHERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427291 ↗MalfunctionMar 16, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE LAD SAFEDAY BLUE NEEDLES CONNECTOR DETACHED FROM THE EXTENSION SET AND SPILLED BLOOD AND RADIOPHARMACEUTICAL CONTAMINANT ALL OVER. DRUG USED WAS MYOVIEW: TECHNETIUM TC99M TETROFOSMIN INJECTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16559066 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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