BioFlo 60M61072182Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H96560M610721820), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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

Recent adverse event reports

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

• MalfunctionDec 16, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A NURSE REPORTED AN ISSUE WITH A BIOSTABLE PICC FROM A TANDEM 5F DL BIOFLO PICC KIT. THE PICC WAS PLACED TO PROVIDE ACCESS FOR MODERATE SEDATION, TO BE USED DURING AN ELECTRO-CONVULSIVE TREATMENT (ECT) A FEW WEEKS LATER. DURING PREPARATION FOR THE ECT PROCEDURE, BLOOD RETURN WAS UNABLE TO BE ESTABLISHED WITH THE TAN LUMEN; HOWEVER, FLUSHING WAS ABLE TO BE PERFORMED, WITHOUT RESISTANCE. THE OTHER LUMEN (PURPLE) IS FULLY FUNCTIONAL. ULTIMATELY, THE ECT PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. AFTER THE PROCEDURE WAS COMPLETED, THE NURSE DISCOVERED THAT THE TAN LUMEN NOW HAD INABILITY TO BE FLUSHED WITH NORMAL SALINE AND BLOOD RETURN COULD NOT BE ESTABLISHED. THE NURSE APPLIED A STICKER TAPE TO THE TAN LUMEN INDICATING IT WAS NOT FUNCTIONAL.  SHE ALSO REPORTED THAT AFTER PICC INSERTION, AND PRIOR TO DISCHARGE FROM THE HOSPITAL, THE PATIENT'S HUSBAND WAS TOLD BY THE BEHAVIORAL NURSE TO FLUSH THE PURPLE LUMEN ONLY AND NOT TO FLUSH THE TAN LUMEN AT HOME.  NO HEPARIN WAS INSTILLED WHILE THE PATIENT WAS AT HOME BY HOME HEALTH AGENCY AND DEVICE WAS ONLY FLUSHED WITH NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996019 ↗