BioFlo 75016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H965750160), received between Jul 19, 2017 and Oct 16, 2017 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2017Fracture; Fracture

  PICC WAS PLACED ON (B)(6) 2017 IN PATIENT'S LEFT UPPER ARM, AND WAS REMOVED ON (B)(6) 2017. THE PICC LINE WAS NOT REPLACED. IT WAS REMOVED BECAUSE A CRACK WAS NOTED BETWEEN THE EXTENSION LEG AND THE HUB JUST BELOW THE WHITE OVERSLEEVE MOLD. THE CRACK WAS DISCOVERED BY THE MOTHER WHILE DRIVING THE PATIENT TO A DOCTOR'S APPOINTMENT. SHE STATED SHE NOTICED BLOOD LEAKING FROM THE PICC LINE. THE PICC WAS BEING USED FOR TPN AND LIPID INFUSION. SITE CARE CONSISTED OF CHG CLEANING EVERY 7 DAYS WITH DRESSING CHANGES, AND THEN SCRUBBING THE HUB WITH ALCOHOL BETWEEN MEDICATION INFUSIONS AND ANY TIME THE LINE WAS ACCESSED. THE PATIENT HAD A BROVIAC TUNNELED CATHETER PLACED THE FOLLOWING DAY POST REMOVAL OF THE PICC LINE. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951814 ↗
• MalfunctionOct 16, 2017Fracture; Fracture

  FEMALE PATIENT (B)(6) YEARS OLD. THE PICC LINE WAS PLACED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2017. THE BEDSIDE NURSE NOTED THE PICC LINE WAS LEAKING DURING A ROUTINE FLUSH. THE LINE WAS CRACKED BETWEEN THE EXTENSION LEG AND THE HUB JUST BELOW THE WHITE OVERSLEEVE MOLD. THE PICC WAS BEING USED FOR CHEMOTHERAPY, AND WAS NOT REPLACED. THE REMAINDER OF THE CHEMOTHERAPY WAS ABLE TO BE INFUSED VIA A PERIPHERAL IV. SITE CARE PROTOCOL: HOSPITAL USES CHG CLEANER EVERY 7 DAYS FOR DRESSING CHANGES AND SCRUBS THE HUB WITH ALCOHOL BETWEEN MEDICATIONS AND ANY TIME THE LINE IS ACCESSED. THE USED DEVICE HAS BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6951809 ↗
• MalfunctionJul 19, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY (B)(6) HOSPITAL, A PATIENT'S PICC LINE, WHICH HAD BEEN PLACED IN THEIR RIGHT ARM, WAS LEAKING AT THE EXTENSION LEG. THE PATIENT'S FATHER HAD STATED THAT THE PATIENT HAD BEEN "PULLING AT THE LINE PRIOR TO THE BLEEDING/LEAKING THAT OCCURRED. " IT WAS INDICATED THAT THE USED PICC WOULD BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724719 ↗