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Medline DYNCSDS14Recalls & reported problems

Medline Industries, Inc. · CATH,CLOSED SUCTION,14FR,DBL,ETT,24HR · Class 1

Adverse event reports
5
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884389125069), received between Oct 18, 2021 and Sep 30, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 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: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem2
  • Tidal Volume Fluctuations2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Respiratory Insufficiency3
  • Increased Respiratory Rate2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Hypoxia1
  • Low Oxygen Saturation1

Recent adverse event reports

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

  • MalfunctionSep 30, 2026Mechanical Problem

    Patient problems: Increased Respiratory Rate; Low Oxygen Saturation

    MAUDE report 50951807 ↗
  • InjuryOct 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY ON (B)(6) 2024, "THERE WAS ANOTHER SUDDEN DROP IN VTE AND VTI. THE RT NOTICED THAT THE INLINE SUCTION CATHETER WOULD NOT STAY LOCKED IN THE OFF POSITION.".

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 20408322 ↗
  • InjuryOct 9, 2024Mechanical Problem; Mechanical Problem

    ACCORDING TO THE CUSTOMER, ON 09/07/2024 THE SUCTION CATHETER WOULD "NOT STAY LOCKED IN THE OFF POSITION" CAUSING A "SUDDEN LOSS OF DELIVERED TIDAL VOLUME WITH INCREASED RR AND DROP IN SPO2" ON A PATIENT RECEIVING MECHANICAL VENTILATION.

    Patient problems: Hypoxia; Increased Respiratory Rate; Respiratory Insufficiency

    MAUDE report 20407581 ↗
  • InjuryOct 18, 2021Tidal Volume Fluctuations

    IT WAS REPORTED THAT A PATIENT THAT WAS ON A VENTILATOR LOST THEIR TIDAL VOLUME AND THEIR OXYGEN SATURATION AS WELL AS BLOOD PRESSURE DROPPED REQUIRING THE SUCTION CATHETER TO BE REPLACED AND PRESSORS TO BE ADMINISTERED TO RESOLVE THE ISSUE.

    Patient problems: Respiratory Insufficiency

    MAUDE report 12651988 ↗
  • InjuryOct 18, 2021Tidal Volume Fluctuations

    IT WAS REPORTED THAT A PATIENT THAT WAS ON A VENTILATOR LOST THEIR TIDAL VOLUME AND THEIR OXYGEN SATURATION DROPPED REQUIRING THE SUCTION CATHETER TO BE REPLACED TO RESOLVE THE ISSUE.

    Patient problems: Respiratory Insufficiency

    MAUDE report 12651750 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.