Chemo Dispensing Pin™ 412014Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04022495095893), received between May 17, 2018 and Jul 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY A B. BRAUN GLOBAL AFFILIATE: I WOULD LIKE TO RAISE THE ATTACHED SUPPLIER CORRECTIVE ACTION. WE HAVE BEEN OBSERVING PRESENCE OF PARTICULATE MATTER IN OUR FINISHED PRODUCT, HENCE WE INVESTIGATED OUR PARTICULATES AND ONE OF THOSE WAS CELLULOSE. ONE OF THE SOURCES WE SUSPECT CELLULOSE TO HAVE EMERGED IS CHEMO DISPENSING PINS MANUFACTURED BY B. BRAUN, AS THIS CONTAINS A PAPER FILTER WITH WHICH OUR PRODUCT COMES IN CONTACT WITH. ALSO, CAN CELLULOSE EMERGE FROM CHEMO DISPENSING PIN PAPER PACKAGING? PLEASE CAN YOU INVESTIGATE IF THERE ARE ANY REPORTED CASES AND ADVICES IF THERE ARE ANY OTHER COMPLAINTS REPORTED AGAINST THIS ITEM?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735454 ↗
• MalfunctionJun 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY A B. BRAUN GLOBAL AFFILIATE: I WOULD LIKE TO RAISE THE ATTACHED SUPPLIER CORRECTIVE ACTION. WE HAVE BEEN OBSERVING PRESENCE OF PARTICULATE MATTER IN OUR FINISHED PRODUCT, HENCE WE INVESTIGATED OUR PARTICULATES AND ONE OF THOSE WAS CELLULOSE. ONE OF THE SOURCES WE SUSPECT CELLULOSE TO HAVE EMERGED IS CHEMO DISPENSING PINS MANUFACTURED BY B. BRAUN, AS THIS CONTAINS A PAPER FILTER WITH WHICH OUR PRODUCT COMES IN CONTACT WITH. ALSO, CAN CELLULOSE EMERGE FROM CHEMO DISPENSING PIN PAPER PACKAGING?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608658 ↗
• MalfunctionMay 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: WHEN THE CHEMO PIN IS ASSEMBLED WITH A 50 ML VIAL OF PACLITAXEL, A 25 ML ETOPOSIDE OR A 16 ML DOCETAXEL, THE PIN CRACKS AND BEGINS TO LEAK A SCANT AMOUNT OF CHEMOTHERAPY ONTO THE STERILE HOOD ENVIRONMENT. THIS OCCURS AFTER THE SECOND OR THIRD TIME IT IS ASPIRATED FROM THE VIAL WITH A SYRINGE. THE NURSE WAS WEARING PPE AND DID NOT HAVE ANY EXPOSURE TO THE SCANT AMOUNT OF CHEMOTHERAPY LEAKED. THE ENVIRONMENT WAS CLEANED PER FACILITY PROTOCOL. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523401 ↗
• MalfunctionMay 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: WHEN THE CHEMO PIN IS ASSEMBLED WITH A 50ML VIAL OF PACLITAXEL, A 25ML ETOPOSIDE OR A 16ML DOCETAXEL, THE PIN CRACKS AND BEGINS TO LEAK A SCANT AMOUNT OF CHEMOTHERAPY ONTO THE STERILE HOOD ENVIRONMENT. THIS OCCURS AFTER THE SECOND OR THIRD TIME IT IS ASPIRATED FROM THE VIAL WITH A SYRINGE. THE NURSE WAS WEARING PPE AND DID NOT HAVE ANY EXPOSURE TO THE SCANT AMOUNT OF CHEMOTHERAPY LEAKED. THE ENVIRONMENT WAS CLEANED PER FACILITY PROTOCOL. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523398 ↗