MEDLINE INDUSTRIES, INC. DYNJ66529BRecalls & reported problems
Medline Industries, Inc. · ANGIOGRAPHY DRAPE PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10198459472831), received between Jan 13, 2026 and Jan 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- Exposure to Body Fluids1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT A "SYRINGE BROKE DURING A PROCEDURE CAUSING BLOOD TO SPLASH ON THE OPERATOR". THE CUSTOMER REPORTED THAT THE CLINICIAN WAS "CLEARING A SYRINGE OF PATIENT'S BLOOD AND IT SHATTERED AND BLOODY FLUID SPRAYED AROUND INCLUDING ON MY FACE AND A FEW DROPLETS IN MY EYE." THE CUSTOMER STATED THAT THE SYRINGE BROKE AT "THE MAIN OUTER CYLINDER." THE CUSTOMER DID NOT REPORT ANY FOLLOW-UP CARE FOR BLOODBORNE EXPOSURE.
Patient problems: Exposure to Body Fluids
MAUDE report 24082066 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A SYRINGE BROKE "ABOUT A MONTH AGO." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE.
Patient problems: Insufficient Information
MAUDE report 24055307 ↗
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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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