NA 7G0400Recalls & reported problems
B. Braun Medical Inc. · GENENTECH TRANSOFIX TRANS DEV · Class 2
Quick summary
This B. Braun needle-free transfer device (Genentech Transofix) is used to move fluid between containers. Most of the 60 reports describe material deforming, blocked flow, or loose particles found inside the fluid path during incoming inspection, along with some contamination and breakage. Two reports mention a death; no injuries were reported, and there are no recalls naming this device.
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
- 60
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04046964345388), received between Oct 17, 2019 and Oct 30, 2025 — classified as 2 deaths, 58 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (33 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation33
- Contamination /Decontamination Problem12
- Obstruction of Flow10
- Device Contaminated During Manufacture or Shipping6
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Known Impact Or Consequence To Patient3
- Death2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
EVENT 2. ACCORDING TO THE COMPLAINANT, DURING INCOMING INSPECTION, PARTICULATE WAS OBSERVED INSIDE THE FLUID PATH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424676 ↗MalfunctionOct 30, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
EVENT 6. ACCORDING TO THE COMPLAINANT, DURING INCOMING INSPECTION, PARTICULATE WAS OBSERVED INSIDE THE FLUID PATH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424665 ↗MalfunctionOct 30, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
EVENT 3. ACCORDING TO THE COMPLAINANT, DURING INCOMING INSPECTION, PARTICULATE WAS OBSERVED INSIDE THE FLUID PATH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424653 ↗MalfunctionOct 30, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
EVENT 5. ACCORDING TO THE COMPLAINANT, DURING INCOMING INSPECTION, PARTICULATE WAS OBSERVED INSIDE THE FLUID PATH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424176 ↗MalfunctionOct 30, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
EVENT 4 ACCORDING TO THE COMPLAINANT, DURING INCOMING INSPECTION, PARTICULATE WAS OBSERVED INSIDE THE FLUID PATH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424174 ↗MalfunctionOct 30, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
EVENT 1. ACCORDING TO THE COMPLAINANT, DURING INCOMING INSPECTION, PARTICULATE WAS OBSERVED INSIDE THE FLUID PATH. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23424157 ↗MalfunctionMay 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1: THREE (3) DEFECTS FOR LOOSE FOREIGN MATERIAL WERE OBSERVED DURING INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059730 ↗MalfunctionMay 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2: THREE (3) DEFECTS FOR LOOSE FOREIGN MATERIAL WERE OBSERVED DURING INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059671 ↗MalfunctionMay 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: THREE (3) DEFECTS FOR LOOSE FOREIGN MATERIAL WERE OBSERVED DURING INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059670 ↗MalfunctionDec 14, 2023Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: A PHARMACY TECHNICIAN REPORTED THAT ON (B)(6) 2023 IN THEIR HOSPITAL ER, THAT THE NURSE SPIKED ONE ACTIVASE 100MG VIAL, HOWEVER THE STERILE WATER DID NOT COME OUT, WOULD NOT FLOW AT ALL. THE RETURNED IMPLICATED TRANSFER DEVICE WAS INSPECTED FOR DEFECTS. AS A RESULT OF THE SAMPLE ANALYSIS, THERE ARE NO DAMAGE OR DEFECTS OBSERVED WITH THE TRANSFER DEVICE. THERE IS NO OBSTRUCTION(S) IN THE FLOW PATHWAYS FOR THE TRANSFER DEVICE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18327338 ↗MalfunctionMar 16, 2023Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: TRANSFER DEVICE FAILED TO TRANSFER DILUENT DURING RECONSITUTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16558619 ↗MalfunctionFeb 10, 2023Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: THE TD USED WAS REPORTED AS NOT ALLOWING THE DILUENT TO FLOW THROUGH. POSSIBLE LOT NUMBERS REPORTED: LOT NUMBER 00VL795563 - PRODUCTION DATE 08/09/2021; EXPIRY DATE 07/31/2026. LOT NUMBER 00VL795567 - PRODUCTION DATE 08/10/2021; EXPIRY DATE 07/31/2026. LOT NUMBER 0061801400 - PRODUCTION DATE 09/15/2021; EXPIRY DATE 08/31/2026. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16350313 ↗MalfunctionDec 12, 2022Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: DURING THE RECONSTITUTION OF THE ACTIVASE 100MG DRUG PRODUCT, ONLY HALF OF THE DILUENT TRANSFERRED TO THE DRUG PRODUCT VIAL BEFORE THE LIQUID TRANSFER UNEXPECTEDLY STOPPED. THE COMPLAINANT INDICATED IT WAS THE TRANSFER DEVICE PROVIDED AS PART OF THE CO-PACKAGED KIT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15965430 ↗MalfunctionNov 11, 2022Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: THE TRANSFER DEVICE CO-PACKAGED WITH ACTIVASE 100MG VIAL DID NOT ALLOW FOR TRANSFER OF THE LIQUID DILUENT TO THE POWDER VIAL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15782418 ↗MalfunctionSep 6, 2022Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: "ACTIVASE 100MG TRANSFER DEVICE WAS MIXING SUPER SLOW, FURTHER CLARIFIED AS TRANSFERRING SLOWLY FROM THE TRANSFER DEVICE FROM ONE VIAL TO THE OTHER." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15361471 ↗MalfunctionSep 6, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE TRANSFER DEVICE BROKE DURING ADMINISTRATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15361454 ↗MalfunctionSep 6, 2022Break; Break
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE TRANSFER DEVICE BROKE DURING ADMINISTRATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15361442 ↗MalfunctionAug 25, 2022Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING RECONSTITUTION, THE TRANSFER DEVICE FOR AN ACTIVASE 100MG VIAL DID NOT ALLOW FOR TRANSFER OF THE LIQUID DILUENT TO THE POWDER VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15292719 ↗MalfunctionAug 24, 2022Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE ACTIVASE 100MG TRANSFER DEVICE WAS MIXING SUPER SLOW, FURTHER CLARIFIED AS TRANSFERRING SLOWLY FROM THE TRANSFER DEVICE FROM ONE VIAL TO THE OTHER. THE DOOR TO NEEDLE TIME WAS 51 MINUTES AND COULD HAVE BEEN FASTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15281393 ↗MalfunctionApr 11, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE INCORRECT DEVICE TRANSFER DEVICE WAS PLACED IN THE KIT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14072829 ↗MalfunctionMar 9, 2022Obstruction of Flow; Obstruction of Flow
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT: ROCHE RECEIVED A COMPLAINT FROM PHARMACIST WHO REPORTED THE FOLLOWING ABOUT ACTIVASE 100 MG TRANSFER DEVICE, ISSUE IDENTIFIED DURING PREPARATION OF THE DRUG: "THE STERILE WATER AND LYOPHILIZED VIALS WERE ABLE TO BE PUNCTURED, BUT STERILE WATER WOULD NOT TRANSFER INTO THE POWDERED VIAL AFTER INVERTING IT WHEN IT NORMALLY FLOWS. A 2ND TRANSFER DEVICE (BORROWED FROM ANOTHER KIT) WAS USED AND SUCCESSFULLY WAS ABLE TO TRANSFER THE STERILE WATER INTO THE POWDERED VIAL. THE VIALS WERE CLARIFIED AS BEING FINE AND THE TRANSFER DEVICE ITSELF MALFUNCTIONED." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13709695 ↗MalfunctionJan 5, 2022Material Deformation; Material Deformation
AS REPORTED BY THE USER FACILITY: EVENT 5: IT WAS REPORTED THAT THE TRANSFER DEVICE WAS DEFORMED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13173082 ↗MalfunctionJan 5, 2022Material Deformation; Material Deformation
AS REPORTED BY THE USER FACILITY: EVENT 6: IT WAS REPORTED THAT THE TRANSFER DEVICE WAS DEFORMED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13173081 ↗MalfunctionOct 19, 2021Material Deformation; Material Deformation
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE TRANSFER DEVICE WAS DEFORMED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12655972 ↗MalfunctionOct 19, 2021Material Deformation; Material Deformation
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE TRANSFER DEVICE WAS DEFORMED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12655967 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.