Skip to content

Medline Industries, Inc. DYNJ46134IRecalls & reported problems

Medline Industries, Inc. · CATH N0 1 STRL MMC PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327162115), received between Mar 28, 2024 and Mar 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Connection Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 28, 2024Connection Problem; Connection Problem

    SYRINGE IS NOT ATTACHING TO NEEDLE CORRECTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19000956 ↗
  • MalfunctionMar 28, 2024Connection Problem; Connection Problem

    SYRINGE IS NOT ATTACHING TO NEEDLE CORRECTLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18998075 ↗

Other Cardiac catheterization kit devices

All Cardiac catheterization kit devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page