Medline ACSDRecalls & reported problems
Medline Industries, Inc. · LUER LOCK ACCESS DEVICE · Class 2
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10193489006070), received between Feb 3, 2021 and Sep 30, 2026 — classified as 3 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Crack3
- Material Integrity Problem2
- Leak/Splash1
- Material Fragmentation1
- Material Protrusion/Extrusion1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information1
- Needle Stick/Puncture1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Crack
It was reported that "2 broken ACSD" and "Both incidents occurred when our ACSD was attached to BD needless connector- MZ1000-07."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947531 ↗MalfunctionSep 21, 2026Break
It was reported that "The tip continues to break crack with no pressure."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841445 ↗MalfunctionSep 19, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833194 ↗MalfunctionSep 11, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741107 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696069 ↗MalfunctionSep 9, 2026Material Integrity Problem
It was reported that "They aren¿t pulling blood like they should." The customer also reported, "They also tried using a syringe to aspirate the needle and that failed as well."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691813 ↗MalfunctionAug 28, 2025Break; Break
THE LUER LOCK WAS BROKEN WHEN THE USER COLLECTED THE BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911997 ↗InjuryMay 11, 2023Break; Break
DEVICE BROKE WHILE CONNECTED TO IV REQUIRING NEW IV SITE TO BE PLACED.
Patient problems: Needle Stick/Puncture
MAUDE report 16913949 ↗InjuryMay 10, 2023Crack; Material Integrity Problem; Crack; Material Integrity Problem
ACCORDING TO THE FACILITY WHEN DRAWING BLOOD FROM AN IV SITE THE LUER PORTION OF THE BLOOD TUBE COLLECTION BARREL BROKE CREATING AN OPEN VENOUS FLOW AND SUBSEQUENT LOSS OF THE IV ACCESS SITE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16902169 ↗MalfunctionJun 16, 2022Leak/Splash; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE NURSE NOTICED LEAKING FROM THE UTILIZED LUMEN AND UPON EXAMINATION FOUND THE PROTRUDING BLUE PIECE FROM THE LUER LOCK ACCESS DEVICE LODGED IN THE MICROCLAVE OF THE PATIENTS PICC LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14712201 ↗InjuryFeb 18, 2021Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE ONGUARD LUER LOCK ACCESS DEVICE WAS HEMOLYZING BLOOD SAMPLES AS WELL AS NOT DRAWING BLOOD SAMPLES WHICH REQUIRED THE NURSE TO USE A SYRINGE ON THE PATIENT TO OBTAIN A BLOOD SAMPLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11345126 ↗MalfunctionFeb 3, 2021Break
IT WAS REPORTED THAT THE LUER LOCK ACCESS DEVICE BROKE OFF INTO THE HUB OF THE IV WHICH RESULTED IN THE IV BEING REMOVED FROM THE PATIENT AND A SECOND IV HAVING TO BE INSERTED.
Patient problems: Insufficient Information
MAUDE report 11275696 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.