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Medical Action Industries 267014Recalls & reported problems

Medical Action Industries Inc. · Kit: IV 100/Cs · Class 2

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

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

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10809160004999), received between Nov 27, 2017 and Apr 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 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 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Break1
  • Component Missing1
  • Contamination /Decontamination Problem1
  • Incomplete or Missing Packaging1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • Abrasion1
  • Insufficient Information1
  • No Information1

Recent adverse event reports

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

  • MalfunctionApr 19, 2024

    THE RN (REGISTERED NURSE) WAS PREPARING TO START AN IV ON A PATIENT. WHEN THE RN WENT TO OPEN THE IV KIT PACKAGING, NOTICED THAT THERE WAS A SMALL, APPROXIMATELY PINPOINT MARK ON THE DRESSING WITHIN THE KIT. THE MARK ON THE DRESSING APPEARS TO POTENTIALLY BE A BUG STUCK TO THE ADHESIVE ON THE DRESSING.

    Patient problems: Insufficient Information

    MAUDE report 19142904 ↗
  • MalfunctionJan 26, 2021Adverse Event Without Identified Device or Use Problem

    WHEN STARTING AN IV ON THIS PATIENT, SCRUBBING WITH THE SPONGE, UNKNOWN IF THERE WAS A PIECE OF PLASTIC OR SOMETHING ON THE SPONGE BUT IT MADE SCRAPE MARKS ON HIS ARM.

    Patient problems: Abrasion

    MAUDE report 11228740 ↗
  • MalfunctionAug 17, 2018Contamination /Decontamination Problem

    STERILITY ISSUE: NURSE WAS GETTING READY TO START IV, LOOKED AT IV START KIT PULLED FROM SUPPLY CART, AND HE NOTICED A HAIR THAT IS SEALED IN PACKAGE. IV START KIT WAS NOT OPENED AND TAKEN TO QUALITY OFFICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7792898 ↗
  • MalfunctionJun 22, 2018Break; Material Integrity Problem

    TOURNIQUET BROKE AND SNAPPED BACK. NO INJURY TO PATIENT. A SECOND DEVICE WITH A DIFFERENT LOT NUMBER ALSO BROKE. CONCERN WAS POTENTIAL HARM TO PATIENT AND EMPLOYEE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7629011 ↗
  • MalfunctionNov 27, 2017Component Missing; Incomplete or Missing Packaging

    ED STAFF STOCKING IV TRAYS WITH MEDICAL ACTION IV START KITS REF (B)(4) LOT 237861 AND AT LEAST (7) SEALED PACKAGES PRESENT IN CASE CONTAINER WITHOUT ANY CONTENTS PRESENT(TOURNIQUET, TAPE, CHLORAPREP FREPP, GAUZE, TEGADERM, OR IV CHANGE LABEL).

    Patient problems: No Information

    MAUDE report 7058618 ↗

Other I.V. start kit devices

All I.V. start kit devices →

Sources and updates

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