NA 610373Recalls & reported problems
B Braun Interventional Systems, Inc · 4F MPK 4CM NDL-018 NT GW PT TIP-STD · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964327483), received between Feb 24, 2021 and Feb 24, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Difficult to Remove1
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2021Break; Difficult to Remove; Physical Resistance/Sticking
AS RECEIVED BY MANUFACTURER FROM END USER/SALES REP. THE GUIDEWIRE BROKE IN THE PATIENT AS IT WAS BEING USED, AND THE PIECE COULD NOT BE RETRIEVED. USING THE 4FR MICRO[?]PUNCTURE KIT, FLEXIBLE TIP WIRE WAS PASSED THROUGH THE WIRE AND MET RESISTANCE. THE WIRE WAS REMOVED AND THE ACCESS NEEDLE ANGLE WAS CHANGED SLIGHTLY WITHOUT REMOVING VEIN ACCESS AND MAINTAINING ASPIRATION OF VENOUS BLOOD. THE FLEXIBLE TIP WIRE WAS PASSED AGAIN AND MET RESISTANCE. IT WAS EASILY REMOVED, BUT ON EXAMINATION AND FLUOROSCOPY IT WAS NOTED THAT THE TIP HAD SHEARED OFF. MULTIPLE FLUOROSCOPIC IMAGES DEMONSTRATED A FIXED WIRE TIP IN THE LOCATION MEDIAL TO THE SUBCLAVIAN OR INTERNAL JUGULAR VEINS.
Patient problems: Foreign Body In Patient
MAUDE report 11374165 ↗
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- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
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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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