BioFlo 46-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965460290), received between May 7, 2022 and May 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2022Fracture; Fracture

  A NURSE REPORTED AN ISSUE WITH A BIOFLO MIDLINE 5F DL-20CM MAX STERILE BARRIER NURSING KIT. DURING A BEDSIDE PLACEMENT PROCEDURE,A MIDLINE WAS SUCCESSFULLY PLACED WITH NO ISSUES WITH THE NEEDLE AND WIRE INSERTION. THERE WAS BLOOD RETURN WHEN THE NEEDLE WAS PLACED. IT WAS REPORTED THAT THERE WAS SOME RESISTANCE WHEN PULLING BACK THE WIRE. WHEN SHE PULLED THE WIRE BACK IT WAS NOTICED PART OF THE WIRE HAD COME OFF IN THE PATIENT. AN X-RAY CONFIRMED THAT THERE WAS A 1.4CM PIECE OF WIRE IN THE PATIENT'S SOFT TISSUE, NEAR THE INSERTION SITE. A SURGEON WAS CONSULTED REGARDING THE REMOVAL OF THE FRAGMENT. THE SURGEON EXPLAINED TO THE PATIENT THE RISKS OF LEAVING THE FRAGMENT IN PLACE TO THE PATIENT AS WELL AS THE POSSIBLE POST SURGICAL REMOVAL ISSUES. IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF NON-COMPLIANCE. THE PATIENT REFUSED SURGERY THEREFORE IT WAS DETERMINED THE FRAGMENT WOULD NOT BE REMOVED. THE MIDLINE WAS REMOVED A FEW DAYS LATER AND PATIENT DISCHARGED WITHOUT INCIDENT. IT WAS REPORTED THAT THE PATIENT WAS A HOMELESS DRUG USER, THEREFORE HE HAD POOR VASCULATURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14314970 ↗