Medline DYNDTC5081BRecalls & reported problems
Medline Industries, Inc. · EXT SET, 8",MINIBORE W/ BOND SMART · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277114838), received between Mar 21, 2024 and May 30, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- Extravasation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD DYNDTC5081B - 8"IV EXT SET NDLE FREE V SLIDE CLMP M/LU HAD FLOW ISSUES IT WAS REPORTED BY THE CUSTOMER THAT CONCERN W/POWER INJECTION. ISSUE OCCURRED WITH A STOKE PATIENT INVOLVED AND SET IS NOT POWER INJECTION RATED AND CAUSED AN EXTRAVASATION ON THIS STROKE PATIENT. I AM NOT GOING TO PRETEND WHAT THAT MEANS. BUT WE HAVE PULLED ALL OF THESE OFF THE SHELF AND NOW HAVE THE B BRAUN PRODUCT IN." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CONCERN W/POWER INJECTION. ISSUE OCCURRED WITH A STOKE PATIENT INVOLVED AND SET IS NOT POWER INJECTION RATED AND CAUSED AN EXTRAVASATION ON THIS STROKE PATIENT. I AM NOT GOING TO PRETEND WHAT THAT MEANS. BUT WE HAVE PULLED ALL OF THESE OFF THE SHELF AND NOW HAVE THE B BRAUN PRODUCT IN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19424643 ↗InjuryMar 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
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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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