Dispensing Pin 413501Recalls & reported problems
B. Braun Medical Inc. · Non-Vented Dispensing Pin with SAFSITE® Valve with Luer Lock Connector · Class 2
All models of Dispensing Pin (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun non-vented dispensing pin is used to transfer IV fluids. Most of the 63 reports describe contamination concerns: users mentioning white particles, matter, or tiny flakes found in the pin cap, on its tips, or left behind in mixing bags and final drug product, plus a few leaks. There are no deaths and no injuries. No recalls name this device. Reports rose from 5 in the earlier 12 months to 14 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 63
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 04022495769756), received between Dec 21, 2016 and May 20, 2026 — classified as 63 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (58 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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem58
- Fluid/Blood Leak2
- Device Contamination with Chemical or Other Material1
- Device-Device Incompatibility1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Known Impact Or Consequence To Patient25
- No Consequences Or Impact To Patient9
- Hemorrhage/Blood Loss/Bleeding1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: A SMALL WHITE PARTICLE WAS OBSERVED IN ONE OF OUR FINAL DRUG PRODUCT BAGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231193 ↗MalfunctionMay 3, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: THE DISPENSING PIN IS LEAVING A PARTICULATE IN THE MIXING BAG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062849 ↗MalfunctionMay 1, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING THE PREPARATION OF UPSTREAM PROCESS, A SIGNIFICANT LEAK WAS OBSERVED OUTSIDE THE CLASS D BIOSAFETY CABINET. THE SAMPLING SYSTEM SEPARATED INTO TWO PIECES. THERE WAS A SUBSTANTIAL LOSS OF PRODUCT AND CELLS, AND A HIGH RISK OF CONTAMINATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25058228 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DISPENSING PIN HAD PARTICULATE MATTER IN THE CAP OF THE DISPENSING PIN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258737 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 9: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563871 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 8: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563870 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 10: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563869 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 6: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563868 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 7: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563866 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 5: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563863 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563862 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563861 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 4: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563860 ↗MalfunctionNov 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: END USER OBSERVED TINY FLAKES ON MULTIPLE TIPS OF THE NON-VENTED DISPENSING PINS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23563859 ↗MalfunctionMay 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: END USER REPORTING DISPENSING PINS HAVING PLASTIC PARTICULATE IN THEM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21975671 ↗MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE CONTINUE TO SEE EXCESSIVE PLASTIC IN USE OF VARIOUS LOT #S FOR THE SPIKE 413501.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961624 ↗MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE CONTINUE TO SEE EXCESSIVE PLASTIC IN USE OF VARIOUS LOT #S FOR THE SPIKE 413501.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961623 ↗MalfunctionMay 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE CONTINUE TO SEE EXCESSIVE PLASTIC IN USE OF VARIOUS LOT #S FOR THE SPIKE 413501.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942484 ↗MalfunctionMay 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: WE CONTINUE TO SEE EXCESSIVE PLASTIC IN USE OF VARIOUS LOT #S FOR THE SPIKE 413501.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21941908 ↗MalfunctionOct 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY, WE HAVE A "NON-VENTED DISPENSING PIN" REF (B)(4) THAT LOOKS LIKE IT HAS MOLD OR SOMETHING SIMILAR ON THE TIP OF THE DISPENSING PIN UNDER THE CAP. WAS SOME BLACK, GREY DARK MATERIAL AT THE END OF THE SPIKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493070 ↗MalfunctionOct 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY, A LITTLE PIECE OF THE SPIKE, LEAVES A LITTLE PIECE OF PLASTIC IN THE SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20474620 ↗MalfunctionOct 11, 2024Device-Device Incompatibility; Device-Device Incompatibility
AS REPORTED WE CONTINUE TO HAVE CORING ISSUES WITH THE B. BRAUN NON VENTED DISPENSING PIN # 413501 - WE HAVE HAD THE ISSUE WITH MULTIPLE LOT#'S.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428913 ↗MalfunctionOct 10, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY USER FACILITY, A LITTLE PIECE OF THE SPIKE, LEAVES A LITTLE PIECE OF PLASTIC IN THE SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20417729 ↗MalfunctionOct 2, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, WE CONTINUE TO HAVE CORING ISSUES WITH THE B. BRAUN NON VENTED DISPENSING PIN # 413501 - WE HAVE HAD THE ISSUE WITH MULTIPLE LOT#'S. THIS IS FOR LOT # 0061932546.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352272 ↗MalfunctionApr 19, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: "WE FOUND A FIBER INSIDE THE TIP OF THE PIN ON PRODUCT 413501. IT WAS REMOVED FROM THE PACKAGE BUT NOT YET USED." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140373 ↗
Other Set, i.V. Fluid transfer devices
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- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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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