Medline Industries, Inc. PAIN9028Recalls & reported problems
Medline Industries, Inc. · CSE 17G HUSTEAD 25G WHIT · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489295689), received between Dec 8, 2022 and Feb 18, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2025Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE NEEDLE BROKE INSIDE THE PATIENT WHILE ATTEMPTING TO ADMINISTER "LOCAL ANESTHESIA" PRIOR TO AN EPIDURAL PLACEMENT.
Patient problems: Foreign Body In Patient
MAUDE report 21403599 ↗InjuryDec 8, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY WHEN ATTEMPTING TO BOLUS MEDICATION THROUGH THE EPIDURAL CATHETER THE PUMP WILL ALARM AND NOT DELIVER THE MEDICATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15940100 ↗
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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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