SAFELINE® NF1320Recalls & reported problems
B. Braun Medical Inc. · Small Bore Extension Set with SafeLine® Split Septum Injection Site · Class 2
All models of SAFELINE (6)
Data updated Oct 18, 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 04046964187223), received between Mar 17, 2021 and Mar 17, 2021 — classified as 4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
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.
MalfunctionMar 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: AFTER A 45 MINUTE WAIT, THE PRODUCT WAS NOTICED TO BE LEAKING BLOOD AT THE PROXIMAL END OF THE COLLAR THAT SCREWS ON TO THE IV CATHETER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504543 ↗MalfunctionMar 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: AFTER A 45 MINUTE WAIT, THE PRODUCT WAS NOTICED TO BE LEAKING BLOOD AT THE PROXIMAL END OF THE COLLAR THAT SCREWS ON TO THE IV CATHETER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504536 ↗MalfunctionMar 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: AFTER A 45 MINUTE WAIT, THE PRODUCT WAS NOTICED TO BE LEAKING BLOOD AT THE PROXIMAL END OF THE COLLAR THAT SCREWS ON TO THE IV CATHETER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504533 ↗MalfunctionMar 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: AFTER A 45 MINUTE WAIT, THE PRODUCT WAS NOTICED TO BE LEAKING BLOOD AT THE PROXIMAL END OF THE COLLAR THAT SCREWS ON TO THE IV CATHETER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504531 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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