BioFlo 44012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965440120), received between Dec 19, 2023 and Dec 19, 2023 — classified as 1 malfunction.

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.

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 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS RECEIVED A USER MEDWATCH (B)(4). A RISK MANAGER REPORTED AN ISSUE WITH A BIOFLO 6F SINGLE PLASTIC FILLED; NON-VALVED. THE FOLLOWING WAS REPORTED: "PATIENT IN CLINIC RECEIVING CHEMOTHERAPY. IMPLANTED PORT-A-CATH (PAC) LOWER RIGHT CHEST LATERAL TO ARMPIT ACCESSED WITH 20-GAUGE 3/4-INCH HUBER NEEDLE, SKIN INTACT; PORT ACCESSED PER PROTOCOL USING ASEPTIC TECHNIQUE, BRISK BLOOD RETURNED ACHIEVED AFTER 2ND RN ASSESSED PLACEMENT AND FLUSH PERFORMED WITHOUT DISCOMFORT, EASILY WITH BRISK BLOOD RETURN. PATIENT IS ABLE TO TASTE SALINE, NEEDLE SECURED WITH TEGADERM DRESSING. KVO FLUIDS INITIATED VIA PAC AND PRE-MEDS ADMINISTERED. PREMEDS GIVEN PER MAR. CHEMOTHERAPY ADMINISTERED SUBSEQUENTLY PER ORDERS; OXALIPLATIN AND LEUCOVORIN ADMINISTERED CONCURRENTLY PER PROTOCOL. PATIENT TOLERATED INFUSION WITHOUT ANY ADVERSE SIDE EFFECTS. POST OXALIPLATIN AND LEUKOVORIN, PATIENT NOTED THAT 'PORT' WAS 'HURTING'. PORT ASSESSED, NO VISIBLE SIGNS OF INFECTION, PORT FLUSHES EASILY, PATIENT ABLE TO TASTE/SMELL, NO BLOOD RETURN NOTED ON FLUSH. ON FURTHER REASSESSMENT AND REMOVAL OF TEGADERM, PATIENT STATES TENDERNESS ABOVE RIGHT BREAST WITHOUT REDNESS, STREAKING OR WARMTH. TREATMENT DISCONTINUED,

  Patient problems: Implant Pain; Pain

  MAUDE report 18357653 ↗