MEDLINE DYNDST1512Recalls & reported problems
Medline Industries, Inc. · IV ADMIN SET, 15DRP, 2 NF PORTS, 108" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884389975954), received between Dec 21, 2023 and Sep 29, 2026 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection5
- Fluid/Blood Leak3
- Mechanical Problem3
- Air/Gas in Device1
- Difficult to Flush1
- Failure to Disconnect1
- Material Integrity Problem1
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937239 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937238 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection
It was reported that the Y-connector on the IV line was leaking near the purple cap.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937237 ↗MalfunctionSep 28, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923966 ↗MalfunctionSep 28, 2026Material Too Soft/Flexible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916056 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889829 ↗MalfunctionSep 24, 2026Mechanical Problem
It was reported that "The nurse anesthetists are complaining about the injection ports failing".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884492 ↗MalfunctionSep 23, 2026Difficult to Flush
It was reported that "We had 2 reports of Medline tubing backflowing."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868080 ↗MalfunctionSep 23, 2026Mechanical Problem
It was reported that "The nurse anesthetists are complaining about the injection ports failing." The customer further reported, "The failure is with the anti-reflux port located most distal, blood has spilled out of the port on several occasions as well as the IV fluid dripping from the same port, thus issues with maintaining sterility are concern as well."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867223 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that "Multiple IV admin sets leaking" and "They had 4 leaks already and it continues to happen over and over."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867135 ↗MalfunctionSep 22, 2026Failure to Disconnect
It was reported that Tubing attached primary line to catheter and not separate and luer lock was damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854988 ↗MalfunctionSep 21, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842092 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that the blue nozzle to the left always leaking liquid when in use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841636 ↗MalfunctionSep 21, 2026Mechanical Problem; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840442 ↗MalfunctionSep 8, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675449 ↗InjuryDec 21, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, THERE HAVE "MULTIPLE" OCCURRENCES WHERE THE "DISTAL PORT BEGINS LEAKING" WITHIN AN "HOUR TO A COUPLE HOURS" OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18377826 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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