MEDLINE OGBCS21GTRecalls & reported problems
Medline Industries, Inc. · BLD COLL SET, 21GX0.75, HOLDER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10197344112074), received between Sep 11, 2026 and Sep 30, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
- Restricted Flow rate3
- Loose or Intermittent Connection2
- Connection Problem1
- Detachment of Device or Device Component1
- Disconnection1
- Material Integrity Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Restricted Flow rate; Loose or Intermittent Connection
It was reported that "the replacement butterfly needles are difficult to use" and "after they connect the holder and begin the draw, they noticed that the vacutainer tubes do not stay very well in the holder and that the blood flow is very slow. Some said that they feel resistance from the vaccum and tube will pop out from the assembly."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951260 ↗MalfunctionSep 24, 2026Fluid/Blood Leak; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885674 ↗MalfunctionSep 24, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884583 ↗MalfunctionSep 22, 2026Restricted Flow rate; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860758 ↗MalfunctionSep 21, 2026Fluid/Blood Leak; Physical Resistance/Sticking
It was reported that "When drawing blood with OnGaurd Blood Collection Sets the hub where the rubber and needle meet is faulty. Allowing blood to continuously flow during the collection process."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839601 ↗MalfunctionSep 17, 2026Restricted Flow rate; Connection Problem
It was reported that "the replacement butterfly needles are difficult to use" and "after they connect the holder and begin the draw, they noticed that the vacutainer tubes do not stay very well in the holder and that the blood flow is very slow." "Some said that they feel resistance from the vaccum and tube will pop out from the assembly."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802035 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
Patient problems: Insufficient Information
MAUDE report 50765000 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
It was reported that "OGBCS21GT leaking while in use" and "the pluger component of the item was loose causing collected blood to leak."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754521 ↗MalfunctionSep 12, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744759 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50740893 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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