Rothbarth G08218Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002082182), received between Aug 21, 2017 and Aug 22, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2017Fracture; Kinked; Fracture; Kinked

  A ROTHBARTH UNI-FLO INFUSION CATHETER WAS USED IN AN ANGIOGRAPHY CATHETER PLACEMENT PROCEDURE ON A (B)(6) OLD PATIENT, WHICH TOOK APPROXIMATELY TWO HOURS. IT WAS REPORTED THAT, THE NURSE WAS PREPARING TO INJECT MEDICATION FOR THROMBOLYSIS AND FOUND A CRACK ON THE CONNECTOR (HUB) OF THE CATHETER. THE PHYSICIAN INSERTED A WIRE GUIDE ALONG THE CATHETER AND WITHDREW IT. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6809809 ↗
• MalfunctionAug 21, 2017Fracture; Fracture

  A ROTHBARTH UNI-FLO INFUSION CATHETER WAS BEING PREPARED TO BE USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT A CRACK WAS OBSERVED ON THE PROXIMAL END (HUB) OF THE CATHETER. THE PHYSICIAN WAS UNABLE TO INJECT THE CONTRAST MEDIUM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6808461 ↗