Extension Set 471959Recalls & reported problems
B. Braun Medical Inc. · Small bore Y-extension set with no injection site · Class 2
All models of Extension Set (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964184512), received between Dec 8, 2020 and Mar 7, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Most reported problems
Device problems
- Fluid/Blood Leak3
- Leak/Splash3
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF DESCRIPTION: BLOOD BACKED UP INTO PORT LINE WITH 5FU RUNNING VIA ELASTOMERIC PUMP. BLOOD LEAKING FROM LEUR CONNECTOR AT Y-SITE ON PUMP SIDE. PT NOTED BLOOD ON HER SHIRT AND CALLED CLINIC. PUMP HAD BEEN RUNNING FOR 21 HOURS (46 HR PUMP). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499293 ↗MalfunctionMar 7, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF FACTUAL DESCRIPTION: BLOOD BACKED UP INTO PORT LINE WITH 5FU RUNNING VIA ELASTOMERIC PUMP. BLOOD LEAKING FROM LEUR CONNECTOR AT Y-SITE ON PUMP SIDE. PT NOTED BLOOD ON HIS SHIRT AND CALLED CLINIC. PUMP HAD BEEN RUNNING FOR 21 HOURS (46 HR PUMP). NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499212 ↗MalfunctionMar 7, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF DESCRIPTION - BLOOD SIPHONING OUT OF PORT INTO TUBING DUE TO LEAK IN BRAUN SMALLBORE Y-TYPE EXTENSION SET AFTER CHEMOTHERAPY PUMP WAS CONNECTED TO PATIENT RESULTING IN PATIENT NEEDING TO RETURN TO CLINIC IN ORDER FOR US TO SHUT OFF PUMP, DE-ACCESS PATIENT PORT RE-ACCESS PATIENT PORT AND HAVE PHARMACY RE-MIX CHEMOTHERAPY IN A NEW PUMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16499201 ↗MalfunctionAug 22, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: PER THE END CUSTOMER, EXT. SET HAS WHAT LOOKS LIKE A HAIR STUCK IN THE CAP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15265044 ↗MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: AS REPORTED BY THE USER FACILITY: "CRACKING IS HAPPENING WHEN SODIUM BICARBONATE IV FLUIDS ARE INFUSING FOR LONG DURATIONS OF TIME. WE UTILIZE SODIUM BICARBONATE FLUIDS FOR LONG DURATION OF TIME, DEPENDING ON THE PATIENTS' URINE PH WHEN WE ADMINISTER OUR HIGH DOSE METHOTREXATE CHEMOTHERAPY REGIMEN. WE HAVE ALSO HAD ISSUES WITH LEUR LOCKS CRACKING WITH INFUSION OF SODIUM BICARBONATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10969417 ↗MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 3: AS REPORTED BY THE USER FACILITY: "CRACKING IS HAPPENING WHEN SODIUM BICARBONATE IV FLUIDS ARE INFUSING FOR LONG DURATIONS OF TIME. WE UTILIZE SODIUM BICARBONATE FLUIDS FOR LONG DURATION OF TIME, DEPENDING ON THE PATIENTS' URINE PH WHEN WE ADMINISTER OUR HIGH DOSE METHOTREXATE CHEMOTHERAPY REGIMEN. WE HAVE ALSO HAD ISSUES WITH LEUR LOCKS CRACKING WITH INFUSION OF SODIUM BICARBONATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10969415 ↗MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: AS REPORTED BY THE USER FACILITY: "CRACKING IS HAPPENING WHEN SODIUM BICARBONATE IV FLUIDS ARE INFUSING FOR LONG DURATIONS OF TIME. WE UTILIZE SODIUM BICARBONATE FLUIDS FOR LONG DURATION OF TIME, DEPENDING ON THE PATIENTS' URINE PH WHEN WE ADMINISTER OUR HIGH DOSE METHOTREXATE CHEMOTHERAPY REGIMEN. WE HAVE ALSO HAD ISSUES WITH LEUR LOCKS CRACKING WITH INFUSION OF SODIUM BICARBONATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10969358 ↗
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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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