BioFlo 75035Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H965750350), received between Jun 9, 2016 and Jun 9, 2016 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER HOSPITAL IS REPORTING A PICC BEING REMOVED AND REPLACED DUE TO CENTRAL LINE-ASSOICATED BLOODSTREAM INFECTION (CLABSI). THE HOSPITAL HAS RECENTLY CHANGED PROTOCOL OF HAVING PICC TEAM PERFORM ROUTINE MAINTENANCE ON PICCS TO HAVING NURSES PERFORM THE MANINTENANCE. THE DEVICE WAS NOT RETAINED. THE CURRENT PATIENT CONDITION IS REPORTED AS DOING WELL.

  Patient problems: Unspecified Infection

  MAUDE report 5708970 ↗
• InjuryJun 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER HOSPITAL IS REPORTING A PICC BEING REMOVED & REPLACED DUE TO CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI). THE HOSPITAL HAS RECENTLY CHANGED PROTOCOL OF HAVING PICC TEAM PERFORM ROUTINE MAINTENANCE ON PICCS TO HAVING NURSES PERFORM THE MAINTENANCE. THE DEVICE WAS NOT RETAINED. THE CURRENT PATIENT CONDITION IS REPORTED AS DOING WELL.

  Patient problems: Unspecified Infection

  MAUDE report 5708955 ↗
• InjuryJun 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER HOSPITAL IS REPORTING A PICC BEING REMOVED & REPLACED DUE TO CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI). THE HOSPITAL HAS RECENTLY CHANGED PROTOCOL OF HAVING PICC TEAM PERFORM ROUTINE MAINTENANCE ON PICCS TO HAVING NURSES PERFORM THE MAINTENANCE. THE DEVICE WAS NOT RETAINED. THE CURRENT PATIENT CONDITION IS REPORTED AS DOING WELL.

  Patient problems: Unspecified Infection

  MAUDE report 5708949 ↗
• InjuryJun 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER HOSPITAL IS REPORTING A PICC BEING REMOVED & REPLACED DUE TO CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI). THE HOSPITAL HAS RECENTLY CHANGED PROTOCOL OF HAVING PICC TEAM PERFORM ROUTINE MAINTENANCE ON PICCS TO HAVING NURSES PERFORM THE MAINTENANCE. THE DEVICE WAS NOT RETAINED. THE CURRENT PATIENT CONDITION IS REPORTED AS DOING WELL.

  Patient problems: Unspecified Infection

  MAUDE report 5708946 ↗