MULTI-AD® 513506Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04022495770394), received between Jun 29, 2021 and Jun 30, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: WHEN PHARMACY TECHNICIAN REMOVED THE PROTECTIVE COVER, THEY NOTICED A BLACK MARK ON THE END OF THE TIP. NO INJURY REPORTED. PER MEDWATCH MW2200350000-2023-8009: PHARMACY TECH WAS PROCESSING AN INTRAVENOUS STERILE COMPOUND PRODUCT THAT REQUIRED RECONSTITUTION WITH STERILE WATER. THE STERILE WATER SET-UP REQUIRES A MULTI-AD FLUID DISPENSING SYSTEM. THE PHARMACY TECH OPENED THE STERILE PACKAGE CONTAINING THE DISPENSING SET, WHEN THEY NOTICED A BLACK BLEMISH/MARK ON THE TIP OF THE TRANSFER SPIKE/NEEDLE. THE PHARMACY TECH DID NOT USE THIS POTENTIAL DEFECTIVE PRODUCT. THE PRODUCT WAS QUARANTINED AND REPORTED TO THE PHARMACIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239854 ↗
• MalfunctionJan 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 4: INSIDE THE SYRINGE THERE IS A JELL-LIKE SUBSTANCE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223807 ↗
• MalfunctionJan 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 3: INSIDE THE SYRINGE THERE IS A JELL-LIKE SUBSTANCE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223806 ↗
• MalfunctionJan 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 5: INSIDE THE SYRINGE THERE IS A JELL-LIKE SUBSTANCE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223805 ↗
• MalfunctionJan 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: INSIDE THE SYRINGE THERE IS A JELL-LIKE SUBSTANCE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223803 ↗
• MalfunctionJan 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: INSIDE THE SYRINGE THERE IS A JELL-LIKE SUBSTANCE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223802 ↗
• MalfunctionJun 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT FOREIGN MATTER WAS OBSERVED ON THE TOP OF THE SYRINGE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084196 ↗