SAFELINE® NF1330Recalls & reported problems
B. Braun Medical Inc. · Microbore Extension Set with SafeLine® Split Septum T-connector · Class 2
All models of SAFELINE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964187247), received between Nov 23, 2016 and Sep 2, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- Leak/Splash3
- Fluid/Blood Leak2
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: END USER REPORTS, "WE ARE HAVING ISSUES WITH OUR T-PORT CONNECTORS FOR IV TUBING. THEY ARE CRACKING AND LEAKING. SAMPLES HAVE BLOOD ON THEM FROM THE LEAKAGE. THIS CAN LEAD TO POTENTIAL INFECTION AND ALSO LOSS OF IVF TO THE PATIENT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419046 ↗MalfunctionSep 2, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: END USER REPORTS, "WE ARE HAVING ISSUES WITH OUR T-PORT CONNECTORS FOR IV TUBING. THEY ARE CRACKING AND LEAKING. SAMPLES HAVE BLOOD ON THEM FROM THE LEAKAGE. THIS CAN LEAD TO POTENTIAL INFECTION AND ALSO LOSS OF IVF TO THE PATIENT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419044 ↗MalfunctionSep 2, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: END USER REPORTS, "WE ARE HAVING ISSUES WITH OUR T-PORT CONNECTORS FOR IV TUBING. THEY ARE CRACKING AND LEAKING. SAMPLES HAVE BLOOD ON THEM FROM THE LEAKAGE. THIS CAN LEAD TO POTENTIAL INFECTION AND ALSO LOSS OF IVF TO THE PATIENT" NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419043 ↗MalfunctionDec 21, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 2: ACCESS PORT (FOR NEEDLELESS ENTRY) LEAKING BLOOD WHEN PLACED ON IV ANGIOCATH AND BLOOD BEING DRAWN WITH A LUER-LOCK SYRINGE. NO PRIOR ACCESS FROM ACCESS PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6196329 ↗MalfunctionDec 21, 2016Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: ACCESS PORT (FOR NEEDLELESS ENTRY) LEAKING BLOOD WHEN PLACED ON IV ANGIOCATH AND BLOOD BEING DRAWN WITH A LUER-LOCK SYRINGE. NO PRIOR ACCESS FROM ACCESS PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6196320 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: LEAKING AT SPINLOCK CONNECTOR DURING BLOOD DRAW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124564 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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