SAFELINE® NF9100Recalls & reported problems
B. Braun Medical Inc. · SafeLine® Injection Site (NF9100) · Class 2
All models of SAFELINE (6)
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 04046964187520), received between Apr 4, 2019 and Sep 4, 2026 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Contamination /Decontamination Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2026Leak/Splash
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50611610 ↗MalfunctionSep 4, 2026Leak/Splash
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50611607 ↗MalfunctionSep 2, 2026Leak/Splash
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50571350 ↗MalfunctionApr 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PHARMACY STAFF HAVE NOTICED THAT WHEN UTILIZING THE 9F90100 SAFELINE INJECTION PORT WITH A NEEDLE, THE INJECTION PORT IS CORING AND A PARTICULATE FORMS IN THE SOLUTION. THE CUSTOMER WAS INFORMED THAT THE SAFELINE 9F90100 IS A NEEDLELESS INJECTION PORT WITH A SPLIT SEPTUM AND THAT THE RECOMMENDED PRODUCT TO USE TO ACCESS THE PORT IS SAFELINE CLIP LOCK CANNULA (NF9200). CUSTOMER WAS INFORMED THAT THE DEVICE IS NOT DESIGNED TO BE USED WITH A NEEDLE AND SHOULD BE PAIRED WITH THE RECOMMENDED DEVICE(S). NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8484464 ↗
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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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