Medline Industries, Inc. PAIN1667ARecalls & reported problems
Medline Industries, Inc. · CONTINUOUS EPIDURAL TRAY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489472868), received between Oct 17, 2022 and Oct 27, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 16, 2024Class IIOpen, Classified
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Z-0509-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Material Integrity Problem1
Patient problems
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2023Material Integrity Problem; Material Integrity Problem
InjuryOct 23, 2023Break; Break
InjuryOct 23, 2023Break; Break
InjuryOct 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY, 'A PATIENT HAD HER EPIDURAL RUNNING AND WAS NOT GETTING COMFORTABLE'. PER THE FACILITY, 'WE FOUND THAT THE CONNECTOR WAS CRACKED, AND THE MEDICATION WAS COMING OUT AND NOT GETTING TO THE PATIENT'.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15620303 ↗
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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 · each recall links to the FDA recall notice
- 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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