MEDLINE DYNA20116Recalls & reported problems
Medline Industries, Inc. · CATHETER, IV, SURESITE AUTO, 20G X 1.16" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489140095), received between Aug 22, 2024 and Oct 1, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE FACILITY ON (B)(6) 2024 , "THEY ATTEMPTED TO START IV PRIOR TO PROCEDURE. THE IV WAS STARTED IN LEFT ARM AND NOTED LEAKING AROUND INSERTION SITE. WHEN REMOVING IV CATHETER, PLASTIC TIP REMAINED IN PATIENT.".
Patient problems: Foreign Body In Patient
MAUDE report 20344804 ↗InjuryAug 22, 2024Material Separation; Material Separation
TODAY WHEN THE DIAGNOSTIC IMAGING STAFF WERE REMOVING THE PATIENT'S IV AFTER A PROCEDURE, THE CATHETER WAS RETAINED IN HER LEFT ARM. THE PATIENT WAS TAKEN TO THE ED AND THEN VASCULAR SURGERY HAD TO DO A CUT DOWN TO EXTRACT THE IV CATHETER FROM THE PATIENT. I'M STILL WAITING TO HEAR BACK FROM THE ED IF THE CATHETER WAS SAVED. AS OF 08/21/2024, WE HAVE NOT YET BEEN INFORMED IF THE CATHETER WAS SAVED.
Patient problems: Foreign Body In Patient
MAUDE report 20031395 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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