SAFELINERecalls & reported problems across all models

We found 6 models of SAFELINE by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Sep 4, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SAFELINE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0713-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported SAFELINE problems

SAFELINE models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SAFELINE® NF1290

  Set, administration, intravascular
  1 recall1 report
• SAFELINE® 352604

  Set, administration, intravascular
  1 recall0 reports
• SAFELINE® NF1251

  Set, administration, intravascular
  1 recall0 reports
• SAFELINE® NF1330

  Set, administration, intravascular
  6 reports
• SAFELINE® NF1320

  Set, administration, intravascular
  4 reports
• SAFELINE® NF9100

  Set, administration, intravascular
  4 reports

Recent SAFELINE adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, THAT A WHITE PIECE APPEARS TO BE LODGED INSIDE THE IV TUBING RIGHT ABOVE THE LOWER Y PORT. THE NURSE TESTED A SET TO SEE IF THE SET IS BLOCKED AND SHE REPORTED THAT THE IV ADMINISTRATION SET IS NOT OCCLUDED. NO INJURIES. THE SET WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7332322 ↗
• 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 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls