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Medline Industries, Inc. DYNJ46134CRecalls & 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 10889942610822), received between Jul 12, 2018 and Sep 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

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

Device problems

  • Dull, Blunt1
  • Obstruction of Flow1

Patient problems

  • Needle Stick/Puncture1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 14, 2018Dull, Blunt

    IT WAS REPORTED THAT A SECOND PUNCTURE WAS REQUIRED AFTER AN INITIAL UNSUCCESSFUL ATTEMPT USING A DULL INTRODUCER NEEDLE.

    Patient problems: Needle Stick/Puncture

    MAUDE report 7876496 ↗
  • MalfunctionJul 12, 2018Obstruction of Flow

    IT WAS REPORTED THAT DURING A LEFT HEART CATHETERIZATION WITH INTERVENTION, UPON REMOVAL OF THE CATHETER FROM THE PATIENT, A "THROMBUS" WAS NOTED ON THE CATHETER, REPORTEDLY FROM THE LINTING OF BLUE OR TOWEL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7682779 ↗

Other Cardiac catheterization kit devices

All Cardiac catheterization kit devices →

Sources and updates

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