MEDLINE DYNDTN1603Recalls & reported problems
Medline Industries, Inc. · IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10080196415076), received between Jul 29, 2022 and Sep 30, 2026 — classified as 3 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (9 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
- Obstruction of Flow9
- Crack6
- Fluid/Blood Leak6
- Difficult to Flush2
- Infusion or Flow Problem2
- Detachment of Device or Device Component1
- Improper Flow or Infusion1
- Increase in Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Crack
It was reported that "we have received several SERS complaints about this tubing being cracked where the syringe connects."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951480 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948190 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947933 ↗MalfunctionSep 29, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937331 ↗MalfunctionSep 29, 2026Obstruction of Flow
It was reported that "saline is not flowing through the tubing."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931153 ↗MalfunctionSep 28, 2026Difficult to Flush; Obstruction of Flow
It was reported that "We are able to draw up medications and push through but when connected to an IV tubing it will not push through the tubing. This has happened with at least 6 of these."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915134 ↗MalfunctionSep 25, 2026Obstruction of Flow
It was reported that "Recently when they connect the syringe and to the extension and the extension to the primary set the syringe will not push the fluid through. The syringe will push when connected to either one independently just not as a set."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898380 ↗MalfunctionSep 25, 2026Loss of or Failure to Bond; Fluid/Blood Leak
It was reported that ¿the following tubing leaking excessively¿ and ¿this has occurred on 3 different occurrences with same lot number.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896594 ↗MalfunctionSep 24, 2026Obstruction of Flow
It was reported that "medication will not push through were it connects to the saline lock."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882527 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Material Separation; Missing Information
It was reported that "tubing leaking excessively."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869619 ↗MalfunctionSep 23, 2026Obstruction of Flow
It was reported that ¿The 8 cs of item dyndtn1603 that she received are unusable due to the inner make connector being too short.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867360 ↗MalfunctionSep 21, 2026Fluid/Blood Leak; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847638 ↗MalfunctionSep 21, 2026Obstruction of Flow
It was reported that ¿they are not letting propofol enter the tube and can¿t use them at all.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839134 ↗MalfunctionSep 19, 2026Difficult to Flush; Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831991 ↗MalfunctionSep 18, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829080 ↗MalfunctionSep 18, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829062 ↗MalfunctionSep 18, 2026Crack
It was reported that we have received several SERS complaints about this tubing being cracked where the syringe connects.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824293 ↗MalfunctionSep 18, 2026Increase in Pressure
It was reported that "High pressure , makes the medication pumps alarm for pressure changes".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823536 ↗MalfunctionSep 18, 2026Crack
It was reported that "we have received several SERS complaints about this tubing being cracked where the syringe connects."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819494 ↗MalfunctionJan 12, 2026Insufficient Device Problem Information
"THE EXTENSION SET PLUNGER IS NOT LONG ENOUGH".
Patient problems: Insufficient Information
MAUDE report 24046219 ↗MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
FLUIDS LEAKING AT CONNECTION POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17589070 ↗MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
FLUIDS LEAKING AT CONNECTION POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17583944 ↗InjuryMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE FACILITY LIPIDS WERE NOTED TO BE LEAKING FROM CRACKED IV TUBING. PER THE FACILITY THE PATIENT DID NOT RECEIVE ALL OF THE LIPID INFUSION AS THE INCIDENT WAS DISCOVERED AFTER THE IV WAS HUNG AND THE LIPIDS WERE INFUSING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16870067 ↗InjuryAug 8, 2022Crack
IT WAS REPORTED THAT ON (B)(6) 2022 DURING A PROCEDURE THE IV TUBING LINE CRACKED AT THE CONNECTION PORT RESULTING IN THE PATIENT NOT RECEIVING THE REQUIRED MEDICATION TO EFFECTIVELY KEEP THEM ASLEEP. ACCORDING TO THE FACILITY THE PATIENT REQUIRED ANESTHESIA INTERVENTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15188330 ↗InjuryJul 29, 2022Crack; Improper Flow or Infusion
IT WAS REPORTED THAT, DURING A PROCEDURE THE IV TUBING LINE CRACKED AT THE CONNECTION PORT CAUSING THE PATIENT TO NOT RECEIVE THE REQUIRED MEDICATION TO EFFECTIVELY KEEP THEM ASLEEP. ACCORDING TO THE FACILITY THE PATIENT REQUIRED ANESTHESIA INTERVENTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15133879 ↗
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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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