Broviac 0600544Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741051838), received between Apr 19, 2017 and Dec 9, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Burst Container or Vessel; Fracture; Stretched; Material Protrusion/Extrusion; Burst Container or Vessel; Fracture; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY EXPLODED WHEN FLUSHED THE LINE PRIOR TO INFUSION. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875843 ↗
• InjurySep 22, 2021Fracture; Material Separation; Migration; Fracture; Material Separation; Migration

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS POST PORT PLACEMENT, THE CATHETER OF THE DEVICE ALLEGEDLY FRACTURED WITH MIGRATION OF THE FRACTURE FRAGMENT OVERLYING THE HEART. REPORTEDLY, THE FRACTURED CATHETER FRAGMENT EMBOLIZED TO THE HEART AND A SURGERY WAS PERFORMED VIA A PERCUTANEOUS PROCEDURE TO RETRIEVE THE FRAGMENT. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pulmonary Embolism

  MAUDE report 12511244 ↗
• MalfunctionApr 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705557 ↗
• InjuryApr 16, 2021Fracture; Failure to Infuse; Malposition of Device; Fracture; Failure to Infuse; Malposition of Device

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT POST PORT DEVICE IMPLANT, THE PORT ALLEGEDLY MISPOSITIONED AND AS A RESULT THE LUNG WAS NOTED TO BE COLLAPSED AND PUNCTURED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Needle Stick/Puncture; Pneumothorax; Pulmonary Embolism

  MAUDE report 11676799 ↗
• MalfunctionApr 15, 2020Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600544 CHRONIC CATHETER ALLEGEDLY EXPERIENCED MATERIAL PUNCTURE/HOLE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) KG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9965321 ↗
• MalfunctionAug 31, 2017Break

  IT WAS REPORTED BY THE FACILITY THAT THE PATIENT PRESENTED WITH A DISTAL PIN-POINT BREAK IN THE BROVIAC. THE FAMILY WAS IN (B)(6) (FOR PATIENT TO RECEIVE JOINT INJECTIONS) EARLIER IN THE DAY WHEN THE BREAKAGE WAS NOTED AND THEY DROVE TO (B)(6) FOR REPAIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836328 ↗
• MalfunctionAug 31, 2017Air Leak; Break

  IT WAS REPORTED BY THE FACILITY THAT THE PATIENT PRESENTED WITH A BROVIAC WITH A BUBBLE IN THE LINE DISTAL TO THE INSERTION SITE AND UNABLE TO USE PER PATIENT'S DAD AND NURSE IN ER. THE BUBBLE OR POSSIBLE BREAK APPEARED TO HAVE CLOSED THE EXIT SITE FOR THE REPAIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836209 ↗
• InjuryApr 19, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FACILITY: "GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED. THE CHEST AND NECK WERE PREPPED AND DRAPED IN A STANDARD STERILE FASHION USING BETADINE PAINT. ACCESS ATTEMPT WAS MADE FROM THE LEFT SUBCLAVIAN POSITION. THERE WAS RETURN OF NONPULSATILE BLOOD. A WIRE WAS ADVANCED USING THE SELDINGER TECHNIQUE WITHOUT RESISTANCE. THE WIRE WAS SEEN ACROSS THE MIDLINE BY FLUOROSCOPIC GUIDANCE AND THE RIGHT BORDER OF THE HEART. IT WAS FELT TO BE SAFELY IN A VENOUS POSITION. AT THIS POINT, A COUNTER INCISION WAS MADE IN THE LEFT ANTERIOR CHEST WALL. A 0.5% BUPIVACAINE WAS INFILTRATED IN SKIN AND SUBCUTANEOUS TISSUES AT THE SITE. A 6.6 FRENCH BROVIAC CATHETER WAS TUNNELED FROM THE ANTERIOR CHEST WALL SITE TOWARDS THE VESSEL PUNCTURE SITE AND DELIVERED. IT WAS MEASURED TO APPROPRIATED SIZE AND CUT. NEXT, UNDER DIRECT FLUOROSCOPIC GUIDANCE, A 7 FRENCH PEEL AWAY SHEATH INTRODUCER WAS ADVANCED OVER THE WIRE TOWARDS THE HEART. AGAIN, IT CROSSED THE MIDLINE AND TURNED TOWARDS THE RIGHT HEART BORDER. NEXT, THE OBTURATOR FROM THE PEEL AWAY SHEATH WAS REMOVED IN ORDER TO PLACE THE CATHETER FORWARD. AT THIS TIME, WE ENCOUNTERED BRIGHT RED HIGH PRESSURE BLOODY RETURN. END RESULT WAS END

  Patient problems: Venipuncture

  MAUDE report 6505005 ↗