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Medline Industries, Inc. DYNJ38868NRecalls & reported problems

Medline Industries, Inc. · PICC LINE INSERTION PACK · Class 2

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

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10198459036835), received between Sep 23, 2026 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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: 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: 3 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Crack1
  • Fracture1
  • Improper Chemical Reaction1
  • Premature Activation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Premature Activation

    It was reported that "We have seen at least 6 PICC packs where the SecurePortIV have been activated. They do not appear cracked or broken, just already popped and unable to be used."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50943989 ↗
  • MalfunctionSep 28, 2026Improper Chemical Reaction

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916404 ↗
  • MalfunctionSep 23, 2026Crack; Fracture

    It was reported that "The 1% Lidocaine vial supplied in the PICC Pack was cracked and leaking fluid in the foam wrapper it comes in. Appeared to have a hairline crack in the bottom of the vial."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50867696 ↗

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Sources and updates

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