Dispensing PinRecalls & reported problems across all models
B. Braun Medical Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 6 models of Dispensing Pin by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and May 20, 2026 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (75 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Reports received per month, all models
Dispensing Pin 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.
- Jan 31, 2022Terminated
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.
Z-0727-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Dispensing Pin problems
Device problems
- Contamination /Decontamination Problem75
- Fluid/Blood Leak3
- Air/Gas in Device1
- Device Contamination with Chemical or Other Material1
- Device-Device Incompatibility1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Known Impact Or Consequence To Patient26
- No Consequences Or Impact To Patient12
- No Patient Involvement4
- Hemorrhage/Blood Loss/Bleeding1
Dispensing Pin models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dispensing Pin 413501Set, i.V. Fluid transfer63 reports
- Dispensing Pin 412005Set, i.V. Fluid transfer1 recall6 reports
- Dispensing Pin 413500Set, administration, intravascular9 reports
- Dispensing Pin 413504Set, administration, intravascular2 reports
- Dispensing Pin 412021Set, i.V. Fluid transfer1 report
- Dispensing Pin 412720Set, i.V. Fluid transfer1 report
Recent Dispensing Pin adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 12, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: RN OPENED THIS AND WAS ABOUT TO ATTACH THE SYRINGE. NOTICED IT LOOKING "WET" AT THE TIP. TOUCHED IT WITH THE SYRINGE AND WE SAW A STRINGY THING. USED MY FINGER AND IT'S SOME SORT OF SUBSTANCE. DIDN'T REACH PATIENT/FIELD. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578394 ↗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 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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