IV Administration Set 352636Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET 15 DR W/2 SAFEDAY · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046955594597), received between Jun 22, 2022 and Jun 5, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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-0670-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Leak/Splash6
- Air/Gas in Device4
- Contamination /Decontamination Problem3
- Inaccurate Flow Rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: CUSTOMER HAD IV TUBING SNAP OFF AT A HUB IN THE OR TODAY, IN THE MIDDLE OF A PATIENT'S ANESTHETIC INDUCTION. NOTHING HAPPENED TO CAUSE IT TO BREAK - THE HUB WASN'T EVEN BEING USED. FLUIDS AND BLOOD WENT ALL OVER THE FLOOR, BLOOD BACKED UP INTO THE IV, AND IT DELAYED SURGICAL START, BUT THE PATIENT WAS NOT HARMED. THE IV TUBING WAS REPLACED AT THE IV SITE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25406770 ↗MalfunctionMay 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SPIKE PORT HAS A MARK ON IT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142870 ↗MalfunctionMay 4, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION SUMMARY: THE AREA WHERE THE BLUE AND CLEAR GO TOGETHER COMES APART. WE HAD PATIENT'S BLOOD EVERYWHERE ALL OVER THE BED AND FLOOR AND THE OTHER ONE WAS IV FLUID THAT WENT EVERYWHERE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071815 ↗MalfunctionMay 3, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1, DESCRIPTION SUMMARY: THE AREA WHERE THE BLUE AND CLEAR GO TOGETHER COMES APART. WE HAD PATIENT'S BLOOD EVERYWHERE ALL OVER THE BED AND FLOOR AND THE OTHER ONE WAS IV FLUID THAT WENT EVERYWHERE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062887 ↗MalfunctionMay 1, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: SALES REP REPORTED THAT THE STAFF FOUND THAT THERE WERE TOO MANY AIR BUBBLES IN THE IV SET THAT THEY COULDN'T GET OUT, AND THAT IT LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055878 ↗MalfunctionDec 10, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: USER STATED THAT AFTER THEY FULLY PRIMED THE IV TUBING, AIR WAS PRESENT BELOW THE SAFEDAY VALVES LATER ON WHEN THEY WENT TO USE THE TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771738 ↗MalfunctionNov 21, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: CUSTOMER REPORTED B BRAUN PRODUCT #352636 LEAKING AND TUBING BREAKING APART AT Y-SITE CONNECTION. RN SAID NURSING STAFF DIDN'T EVEN PULL-ON TUBING IT JUST FELL APART. THE RN WAS PREFORMING A FLUSH FOLLOWING CHEMO TREATMENT. NO STAFF OR PATIENTS WERE INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617229 ↗MalfunctionJun 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: WE USE YOUR BRAUN SAFEDAY IV ADMINISTRATION SET AT OUR CENTER. I HAD 2 CONCERNS ABOUT THE TUBING TODAY FROM NURSES. WHEN A NURSE REMOVED THE CAP OVER THE SPIKE (WHICH GOES INTO IV FLUID BAG) THERE WAS A HAIR WRAPPED AROUND THE STERILE TIP. ANOTHER TUBING TODAY, THE NURSE REMOVED THE CAP TO ATTACH IT TO THE PATIENT'S IV, THERE WAS AN EYELASH ON THE STERILE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366749 ↗MalfunctionJun 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: WE USE YOUR BRAUN SAFEDAY IV ADMINISTRATION SET AT OUR CENTER. I HAD 2 CONCERNS ABOUT THE TUBING TODAY FROM NURSES. WHEN A NURSE REMOVED THE CAP OVER THE SPIKE (WHICH GOES INTO IV FLUID BAG) THERE WAS A HAIR WRAPPED AROUND THE STERILE TIP. ANOTHER TUBING TODAY, THE NURSE REMOVED THE CAP TO ATTACH IT TO THE PATIENT'S IV, THERE WAS AN EYELASH ON THE STERILE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366737 ↗MalfunctionFeb 24, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION INFUSION WAS COMPLETE AND AIR INFUSED INTO THE PATIENT. DESCRIPTION OF THE PATIENT EVENT PATIENT WAS A NURSE AND RECOGNIZED THIS SHOULD NOT BE HAPPENING AND ALERTED SOMEONE BEFORE THE SITUATION BECAME DANGEROUS. THEY WERE USING A PRESSURE CUFF ON A B BRAUN L8001 BAG WHEN THE LINE RAN DRY AND AIR BEGAN INFUSING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18774504 ↗MalfunctionJan 29, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ROLLER CLAMP DID NOT WORK. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18596340 ↗MalfunctionAug 3, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF THE PATIENT EVENT: TUBING CAME APART AT Y-SITE DURING PROCEDURE AND ENDED UP REPLACING THE IV ADMIN SET WITH A NEW IV ADMIN SET. LEAKAGE OF BLOOD MAY HAVE OCCURRED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17449515 ↗MalfunctionJun 22, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "I WENT TO CONNECT MY PATIENT TO A PRIMARY BAG OF NORMAL SALINE TO GIVE HIM HIS PRE-MEDICATIONS PRIOR TO CHEMO, AND THE TUBING CAME DISCONNECTED TOP Y-SITE. THE TUBING WAS LEAKING FROM THE BAG ALL OVER THE GROUND, AND THE TUBING CONNECTED TO THE PATIENT BEGAN SUCKING AIR THROUGH IT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14774006 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.