Medline DYNDTN1545Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10080196760022), received between Jul 1, 2024 and Sep 30, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947100 ↗
• MalfunctionSep 29, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933433 ↗
• MalfunctionSep 28, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923505 ↗
• MalfunctionSep 28, 2026Difficult to Flush; Material Deformation

  It was reported that 10 PACKS WOULD NOT DRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910616 ↗
• OtherSep 25, 2026Physical Resistance/Sticking

  It was reported that THE LUER LOCK PART THAT ATTACHES THE TUBING TO THE IV CATHETER HAS BEEN GETTING STUCK RESULTING IN DIFFICULTY IN ATTACHING THE TUBING TO THE IV. THE LUER LOCK PART IS OFF SET FROM TEH CENTER RESULTING IN IT GETTING STUCK AND NOT THREADING ON THE IV CATHETER EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896922 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886290 ↗
• MalfunctionSep 24, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884276 ↗
• MalfunctionSep 24, 2026Difficult to Flush; No Flow; Air/Gas in Device

  It was reported that "The product does not allow fluid through the spike adapter."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884091 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak; Mechanical Problem

  It was reported that the plastic tubing is too stiff, and it is hard to tape it down and orient the tubing to where the ports are facing anesthesia. Also, when you use the rolling clamp, even though it¿s tightened all the way, it can still leak fluid from the end.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877395 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  It was reported that "Our surgery Dept said that this case of Tubing leaks."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871215 ↗
• MalfunctionSep 22, 2026Material Deformation

  It was reported that there is a kink in the tubing and cannot be used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855442 ↗
• MalfunctionSep 22, 2026Packaging Problem

  It was reported that "There have been cracks in the portion of the tubing that connects to the IV catheter. After tightly connecting the tubing to the IV, there has been a visible leakage of blood or IV fluids, leaking onto the sheets."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50853418 ↗
• MalfunctionSep 21, 2026Material Deformation

  Patient problems: Insufficient Information

  MAUDE report 50848284 ↗
• MalfunctionSep 21, 2026Disconnection; Structural Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842930 ↗
• MalfunctionSep 21, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841879 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  It was reported that ITEMS WERE LEAKING FLUID FROM THE HUB AFTER IT HAS BEEN SPIKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827097 ↗
• MalfunctionSep 15, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779261 ↗
• MalfunctionMar 30, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT BD GRAVITY AET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT NO FLUID FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729805 ↗
• MalfunctionMar 30, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BD GRAVITY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT NO FLUID FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728460 ↗
• MalfunctionMar 22, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET WAS LEALING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE TUBING LEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24658923 ↗
• MalfunctionOct 14, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD IV GRAVITY SET; FOREIGN MATTER NOTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE - PARTICULATES ON COMPONENT BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440171 ↗
• MalfunctionJul 1, 2024Material Integrity Problem; Material Integrity Problem

  TUBING CAME APART AT THE Y PORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650693 ↗