MEDLINE BCLLADRecalls & reported problems
Medline Industries, Inc. · BLOOD CULTURE, LUER LOCK ACCESS DEVICE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10193489189650), received between Jun 28, 2024 and Sep 29, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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
- Fluid/Blood Leak10
- Break3
- Material Twisted/Bent2
- Retraction Problem2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Exposure to Body Fluids1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Fluid/Blood Leak; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933120 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931348 ↗MalfunctionSep 23, 2026Break; Fluid/Blood Leak; Material Twisted/Bent
It was reported that "the new blood culture cavutainers are very flimsy and the needles are bending and breaking frequently. A nurse said the needle continued to drip a large amount of blood after he deisengaged a blood culture bottle yesterday."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866932 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that blood "shot out of the needle" following the removal of the vial.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845671 ↗MalfunctionSep 18, 2026Fluid/Blood Leak; Retraction Problem
It was reported that "When removing the first bottle, the sheath over the needle did not retract back causing blood to leak out of the exposed needle."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819098 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was reported that customer was using luer lock and had blood spray out on patient.
Patient problems: Exposure to Body Fluids
MAUDE report 50803099 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
It was reported that blood "shot out of the needle" following the removal of the vial.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793088 ↗MalfunctionSep 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746562 ↗MalfunctionSep 11, 2026Break; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735174 ↗MalfunctionSep 11, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735113 ↗MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
STAFF IN OUR ED NOTICED THE NEEDLE INSIDE THE DEVICE WAS BENT AND CAUSE ISSUES TRYING TO INSERT A BLOOD TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639986 ↗
Other Tubes, vials, systems, serum separators, blood collection devices
- BD Vacutainer® SST™ 367986Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls2,711 reports
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes 363083Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall1,744 reports
- BD Vacutainer® SST™ II Advance 367955Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection1,478 reports
- BD Vacutainer® Eclipse™ Blood Collection Needle 368607Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,220 reports
- BD Vacutainer® SST™ 367983Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection2 recalls1,075 reports
- BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes 367856Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1,010 reports
- BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units 367960Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall747 reports
- BD Vacutainer® SST™ II Advance 367957Becton, Dickinson U.K. Limited · Tubes, vials, systems, serum separators, blood collection767 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page