Medline DYNDTC5002Recalls & reported problems
Medline Industries, Inc. · IV EXT SET, 7", 0.1ML, BONDED NF VALVE · Class 2
Data updated Oct 16, 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 10884389719749), received between Aug 8, 2024 and Aug 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inaccurate Flow Rate” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inaccurate Flow Rate2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED THAT BD EXTENSION SET WAS UNDER INFUSING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM; IV START KIT WAS OBSERVED TO BE AT A 1.5ML/SECOND FLOW RATE AT A MAXIMUM PSI OF 300". PER THE FACILITY "THAT IS TOO LOW OF A FLOW RATE FOR POWER INJECTION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937715 ↗MalfunctionAug 8, 2024Inaccurate Flow Rate; Inaccurate Flow Rate
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937479 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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