Dispensing Pin 413500Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04022495769749), received between Oct 16, 2018 and May 5, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (8 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: PLASTIC PARTICULATES WHEN USING THESE DISPENSING PINS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961158 ↗
• MalfunctionMar 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: THE CUSTOMER IS EXPERIENCING A PIECE OF PLASTIC FLOATING IN THE BAG AFTER SPIKING WITH NON-VENTED DISPENSING PINS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526980 ↗
• MalfunctionJul 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: PROBLEM: END USER STATED THAT THEY ADDED STEM CELLS TO THE BAG VIA THE DISPENSING PIN LAST NIGHT VIA THE MED ADD PORT. THE BAG THEN SAT OVERNIGHT. THE NEXT MORNING WHEN THE BAG WAS INVERTED, IT WAS FOUND TO HAVE THE SAFESITE VALVE PORTION OF THE DISPENSING PIN FULL OF STEM CELL PRODUCT AND LEAKING BLOOD. THE BAG WAS SPIKED WITH AN INFUSION SET ON THE SPIKE PORT. NO OTHER ADDITIONS WERE MADE. CUSTOMER STATED THEY TOOK THE PIN OUT OF THE MED ADD PORT TO INSPECT THE ISSUE THEMSELVES. THEY ONLY HAVE THE PIN TO SEND IN. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770959 ↗
• MalfunctionJan 16, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT PRODUCT DP3500 DISP PIN LS REFLUX WAS ASSEMBLED TO BAXTER MINIBAG AND UPON INSPECTION BY PHARMACIST, PLASTIC CHARDS WERE FOUND FLOATING INSIDE THE BAGS. DENIES ANY PLASTIC FLOATING PRIOR TO USE OF THE DISPENSING PINS. NO INJURIES REPORTED

  Patient problems: No Patient Involvement

  MAUDE report 8253282 ↗
• MalfunctionJan 16, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT PRODUCT DP3500 DISP PIN LS REFLUX WAS ASSEMBLED TO BAXTER MINIBAG AND UPON INSPECTION BY PHARMACIST, PLASTIC CHARDS WERE FOUND FLOATING INSIDE THE BAGS. DENIES ANY PLASTIC FLOATING PRIOR TO USE OF THE DISPENSING PINS. NO INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8253280 ↗
• MalfunctionJan 16, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT PRODUCT DP3500 DISP PIN LS REFLUX WAS ASSEMBLED TO BAXTER MINIBAG AND UPON INSPECTION BY PHARMACIST, PLASTIC CHARDS WERE FOUND FLOATING INSIDE THE BAGS. DENIES ANY PLASTIC FLOATING PRIOR TO USE OF THE DISPENSING PINS. NO INJURIES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8253277 ↗
• MalfunctionNov 5, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT PARTICULATE MATTER WAS SEEN FLOATING IN BAG IN USE WITH THE DISPENSING PIN. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037422 ↗
• MalfunctionOct 16, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: PARTICULATE MATTER FLOATING IN BAG IN USE WITH DISPENSING PIN. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968804 ↗
• MalfunctionOct 16, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: PARTICULATE MATTER FLOATING IN BAG IN USE WITH DISPENSING PIN. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968796 ↗