Broviac 0600044Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741036316), received between Apr 6, 2016 and Sep 11, 2021 — classified as 2 injuries, 2 malfunctions.

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

• InjurySep 11, 2021Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT POST CHRONIC CATHETER PLACEMENT, THE DEVICE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT SURGERY WAS PERFORMED AND THE LINE WAS REMOVED AND REPLACED WITH A NEW LINE. THE PATIENT WAS REPORTEDLY STABLE.

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

  MAUDE report 12457658 ↗
• MalfunctionMar 23, 2017Crack

  IT WAS REPORTED BY THE FACILITY THAT A CRACK WAS FOUND IN THE CATHETER AND IT WAS SUBSEQUENTLY REMOVED IN E.R.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6430247 ↗
• MalfunctionJan 18, 2017Unintended Ejection; Restricted Flow rate; Difficult to Flush; Noise, Audible

  ON 12/30/16 - FACILITY REPORTED THAT A BROVIAC 2.7 FR LINE WAS PLACED INTO THE BABY'S LEFT GROIN AT (B)(6). HAD BEEN RUNNING PEDIATRIC TPN AT VARIOUS RATES AS BABY GOT OLDER. TPN RATE HAD STARTED OUT AT 21.5ML / HR WHEN EVENT OCCURRED. THE PATIENT'S NURSE HAD CALLED THE RN MANAGER TO BEDSIDE TO EVALUATE THE BROVIAC CATHETER DUE TO THE DIFFICULTY GETTING BLOOD RETURN. THE DRESSING WAS REMOVED TO SEE LINE, UPON STRAIGHTENING THE LINE, BLOOD RETURN WAS IMPROVED AND LINE WAS FLUSHING WITHOUT DIFFICULTY. NURSE CONNECTED PEDIATRIC TPN TO ALARIS PUMP. WHEN PUMP STARTED THE NURSE NOTICED BLOOD BACKING UP INTO THE LINE. WHEN THEY WERE UNCOVERING THE LINE DRESSING, A POP WAS HEARD AND THERE WAS SPLATTERING OF SALINE, TPN AND BLOOD. NO PATIENT INJURY WAS REPORTED. ON 1/13/16- RECEIVED ADDITIONAL MEDWATCH REPORT STATING, "BABY BORN WITH COMPLICATION FROM EXPOSURE TO MOTHER'S USE OF IV HEROIN, METHADONE AND NO PRENATAL CARE. THE BROVIAC CATHETER PLACED INTO LEFT GROIN VEIN FOR ADMINISTRATION OF TPN/LIPIDS SECONDARY TO FEEDING INTOLERANCE. APPROXIMATELY FOUR WEEKS LATER THE PATIENT'S RN CALLED CN TO HELP EVALUATE BROVIAC DUE TO DIFFICULTY GETTING BLOOD RETURN. REMOVED DRESSING TO SEE LINE AND UP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6261033 ↗
• InjuryApr 6, 2016Break; Migration or Expulsion of Device

  NURSE REPORTED THAT A TWO MONTH OLD PATIENT HAD A BROVIAC PLACED IN THE RIGHT SAPHENOUS VEIN ON (B)(6) 2016. ON (B)(6) 2016 AN X-RAY WAS TAKEN AND IT WAS NOTED THAT A PIECE OF THE CATHETER HAD BROKEN INSIDE THE PATIENT AND HAD MIGRATED TO THE LEFT PULMONARY ARTERY. PHYSICIANS REVIEWED PAST X-RAYS TAKEN AND DETERMINED THAT THE CATHETER BROKE ON (B)(6). THEY INITIALLY THOUGHT THE PIECE WAS PART OF THE LEADS FROM THE PATIENT'S PERMANENT PACE MAKER. THE REPORTED BROKEN PIECE WAS REMOVED BUT THE LINE CURRENTLY REMAINS IN PATIENT. THE NURSE STATED THAT THE LINE WILL BE REPLACED IN THE FUTURE.

  Patient problems: No Code Available

  MAUDE report 5552875 ↗