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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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