Medline PAIN8021Recalls & reported problems
Medline Industries, Inc. · NEEDLE, QUINCKE, 18GX3.5" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884389848234), received between Sep 10, 2026 and Sep 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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
- Physical Resistance/Sticking4
- Detachment of Device or Device Component2
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem
It was reported that "THE NEEDLE ITSELF IS SCRAPING AGAINST THE SHEATH COVER WHEN STAFF PULLS IT OFF AND IT'S DAMAGING THE NEEDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947818 ↗MalfunctionSep 30, 2026Physical Resistance/Sticking
It was reported that "The inside stylet piece is super hard to get out and in with a lot of the needles" and "Some of them are physically stuck and won't budge at all."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947040 ↗MalfunctionSep 17, 2026Physical Resistance/Sticking
It was reported that "Well we have quite a few 18g spinal needles, all the same lot number, that the stylets are hard to remove or will not come out."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803767 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724450 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722612 ↗
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- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- 22G 1 1/2IN Regional Block Needle 408348Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- BD QUINCKE Spinal Needles 405180Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)23 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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