MEDLINE EBSI1742Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10653160374770), received between May 27, 2025 and Jun 13, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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.

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.

• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT THE "THE FLUSH SYRINGE FLANGE IN THE KIT WAS BROKEN WHEN KIT WAS OPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205288 ↗
• MalfunctionJun 12, 2025Material Integrity Problem; Material Integrity Problem

  FLANGE OF SYRINGE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193558 ↗
• MalfunctionMay 30, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2025 "THE NURSE STATED THAT THE FLUSH SYRINGE FLANGE IN THE KIT WAS BROKEN WHEN KIT WAS OPENED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114896 ↗
• MalfunctionMay 27, 2025Material Integrity Problem; Material Integrity Problem

  THE FLANGE ON THE SIDE OF THE SYRINGE WAS COMPROMISED, AND BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089135 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 "THE FLANGE ON THE SIDE OF THE SYRINGE WAS COMPROMISED AND BROKE OFF" WHILE FLUSHING THE LINE DURING A DRESSING CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087990 ↗