Medline DYNDTN1545DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10080196714933), received between Feb 23, 2024 and Sep 24, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Loose or Intermittent Connection

  It was reported that BD smartsite needle free connector had connection issues.The following information was received by the initial reporter with the following Verbatim.It was reported by customer that Luer locks to the 3-way stopcock will either be barely tight or completely loose. If the patient moves around or the tubing has any tension on it, it may disconnect. They have noticed these have been loose straight out of the packaging for some time now.

  Patient problems: Insufficient Information

  MAUDE report 50889800 ↗
• MalfunctionSep 21, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841642 ↗
• MalfunctionSep 16, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796088 ↗
• MalfunctionJun 19, 2026Infusion or Flow Problem; Separation Problem

  IT WAS REPORTED THAT THE TUBING DISCONNECTED AND THERE WAS BLOOD BACK FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25568608 ↗
• MalfunctionMay 15, 2026Obstruction of Flow

  IT WAS REPORTED ON 04/15 THAT A NURSE SPIKED A BAG OF IV FLUIDS AND ATTEMPTED TO PRIME THE IV LINE; HOWEVER, THE LINE DID NOT PRIME. UPON INSPECTION, THE NURSE OBSERVED THAT THE TUBING APPEARED TO BE SEALED JUST BELOW THE DRIP CHAMBER, PREVENTING FLUID FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194662 ↗
• MalfunctionMay 15, 2026Loose or Intermittent Connection

  TUBING DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184546 ↗
• MalfunctionMay 11, 2026Backflow; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE BD GRAVITY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER REGARDING ONE OF YOUR PRODUCTS. CUSTOMER REPORT: ¿CUSTOMER STATES TUBING CAME DISCONNECTED AT THE MANIFOLD. IV FLUIDS RAN OUT ALL OVER THE FLOOR AND A SMALL AMOUNT OF BLOOD BACK FLOWED TO THE FLOOR, 1 INCH PUDDLE ON FLOOR. IV TUBING WAS PUT TOGETHER BY ANOTHER STAFF MEMBER.¿ ADDITIONAL QUESTIONS HAVE BEEN SENT TO THE CUSTOMER. FINISHED GOOD #: DYNDTN1545. FINISHED GOOD LOT #: 25125257. PRODUCT DESCRIPTION: IV ADMIN SET,15DR,4NFPORTS, STPCOCK,109." DATE REPORTED: 4/16/2026. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿THE TUBING IS SET UP TO FREE FLOW, NOT ON A PUMP. THE TUBING IS COMING APART AT THE CONNECTION WITH THE STOPCOCK.¿ CUSTOMER WAS UNABLE TO PROVIDE INFORMATION REGARDING THE MANIFOLD COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 25141822 ↗
• MalfunctionFeb 6, 2026Disconnection; Connection Problem

  IT WAS REPORTED THAT THE BD GRAVITY SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COMPLAINT IS THAT THE CONNECTORS ARE NOT TIGHT WHEN TAKEN OUT OF THE PACKAGE, SO WHEN THE CLINICIANS PRIME IV FLUID, IT WILL LEAK FROM THE CONNECTORS, OR THE CONNECTORS WILL BECOME DISCONNECTED COMPLETELY. SO NOW, THE CLINICIANS ARE HAVING TO TAKE EXTRA TIME CHECKING ALL THE CONNECTORS BEFORE PRIMING TUBING EACH TIME. THIS PRIMARILY HAPPENS AT THE YELLOW 3 WAY CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282909 ↗
• MalfunctionFeb 23, 2024Blocked Connection; Blocked Connection

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: DYNDTN1545 BATCH#: 23095709 IT WAS REPORTED BY CUSTOMER THAT BLOCKAGE, OCCLUSION IN THE SPIKE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BLOCKAGE, OCCLUSION IN THE SPIKE DATE OF EVENT: 30JAN2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769359 ↗