MEDLINE DYNA20100Recalls & reported problems
Medline Industries, Inc. · CATHETER, IV, SURESITE AUTO, 20G X 1.00" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489140101), received between Aug 22, 2024 and Sep 24, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Fail-Safe Did Not Operate1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884625 ↗MalfunctionJun 12, 2026Activation Failure; Fail-Safe Did Not Operate
WE RECEIVED FEEDBACK FROM CUSTOMERS REGARDING TWO SEPARATE INSTANCES OF THE NEEDLES NOT RETRACTING PROPERLY IN MEDLINE SURESITE AUTO SAFETY IV CATHETERS. BOTH FEEDBACKS WERE REGARDING THE FOLLOWING: PART #: DYNA20100, LOT #: 27824110001. BOTH FEEDBACKS STATED "NEEDLE DOES NOT RETRACT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491420 ↗InjuryOct 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY "WHEN INSERTED INTO THE VEIN TO START THE IV, IT STICKS TO THE NEEDLE AND DOES NOT RESULT IN A SMOOTH EXTRACTION OF THE NEEDLE FROM THE CATHETER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578507 ↗InjuryAug 22, 2024Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN REMOVING THE IV CATHETER AFTER A "HEART CORONARY ANGIOGRAPHY" THE CATHETER WAS RETAINED IN THE PATIENT'S "LEFT MEDIAN ANTECUBITAL VEIN".
Patient problems: Foreign Body In Patient
MAUDE report 20031052 ↗
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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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