Medline Industries, Inc. DYNDC2409ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10889942805693), received between Feb 11, 2022 and Sep 23, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2022Device Damaged Prior to Use; Defective Component

  INFUSION THERAPY: WHEN REMOVING THE MEDLINE, PORT ACCESS FROM PACKAGING, THE PROTECTIVE WINGS WERE ALREADY OVER THE NEEDLE. NOT USED ON PATIENT. REP - CHRIS HALL PICKED UP THE PRODUCT. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). OBTAINED AND WILL INVESTIGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470117 ↗
• MalfunctionSep 20, 2022Component Missing; Defective Device

  MID 30¿S FEMALE WITH HISTORY OF BREAST CANCER. PROCEDURE: INFUSION TREATMENT. WHEN THE KIT WAS OPENED, THE HUBER NEEDLE WAS WITHOUT A PLASTIC SHEATH AND PARTIAL SAFETY CLIP CLOSURE. NOT USED ON PATIENT. THIS IS THE 4TH REPORT FOR NONACCEPTABLE NEEDLE. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454634 ↗
• MalfunctionAug 2, 2022Collapse; Device Damaged Prior to Use

  MID 60¿S FEMALE WITH HISTORY OF UTERINE CORPUS CANCER. PROCEDURE: INFUSION TREATMENT. WHEN THE PORT ACCESS KIT WAS OPENED, THE PORT NEEDLE WAS COLLAPSED AND UNUSABLE. NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146098 ↗
• MalfunctionJul 28, 2022Component Missing

  MID 50¿S FEMALE WITH HISTORY OF ADENOCARCINOMA OF THE LEFT BREAST. PROCEDURE: INFUSION THERAPY. THE PROTECTION SHEATH OVER THE PORT NEEDLE WAS MISSING WHEN OPENED FROM THE PACKAGING. NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120910 ↗
• MalfunctionFeb 11, 2022Packaging Problem

  PATIENT ARRIVED FOR INFUSION THERAPY. WHEN PREPPING FOR INFUSION, THE MEDLINE PORT ACCESS KIT SAFETY SHIELD WAS ALREADY PULLED OVER THE NEEDLE PRIOR TO THE PACKAGE BEING OPENED. COSTLY PRODUCT NOT ABLE TO BE USED. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, MEDLINE INDUSTRIES, INC. (PER SITE REPORTER). WILL INVESTIGATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13513682 ↗