Dispensing Pin 412005Recalls & reported problems
B. Braun Medical Inc. · Standard Spike Dispensing Pin with SAFSITE® Valve with Luer Slip Connector · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04022495769633), received between Mar 19, 2021 and Apr 21, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS FOREIGN MATTER DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11699139 ↗MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS FOREIGN MATTER DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11527003 ↗MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS FOREIGN MATTER DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526985 ↗MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS FOREIGN MATTER DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526984 ↗MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY EVENT 1: CUSTOMER REPORTS FOREIGN MATTER DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526972 ↗MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY EVENT 3: CUSTOMER REPORTS FOREIGN MATTER DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526970 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.