Broviac 0600040Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00801741036309), received between Dec 3, 2015 and Jan 12, 2026 — classified as 16 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Fracture; Material Protrusion/Extrusion

  A PATIENT UNDERWENT A PLACEMENT PROCEDURE OF BROVIAC CV CATHETER. POST PROCEDURE AFTER TWELVE DAYS OF PLACEMENT IT WAS REPORTED THAT A CHRONIC CATHETER APPEARS TO BE BROKEN INTERNALLY. THE RIGHT LEG ALSO APPEARS TO BE PUFFY WHERE THE BROVIAC IS PLACED. FURTHER, REMOVED IN INTERVENTIONAL RADIOLOGY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 24033498 ↗
• MalfunctionApr 9, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  IT WAS REPORTED THAT DURING INSTALLATION OF A CHRONIC CATHETER PLACEMENT PROCEDURE, THE DEVICE RIGID PORTION WAS ALLEGEDLY FOUND LONGER THAN THE ORIGINAL. IT WAS FURTHER REPORTED THAT THE CUFF IS IN A DIFFERENT LOCATION THAN INDICATED ON THE LABELING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21805046 ↗
• MalfunctionNov 23, 2024Partial Blockage; Material Discolored; Restricted Flow rate; Deformation Due to Compressive Stress; Contamination /Decontamination Problem; Partial Blockage; Material Discolored; Restricted Flow rate; Deformation Due to Compressive Stress; Contamination /Decontamination Problem

  IT WAS REPORTED THAT TEN MONTHS AND NINETEEN DAYS POST A CHRONIC CATHETER PLACEMENT VIA THE RIGHT EXTERNAL JUGULAR VEIN, THE WHITE PLASTIC PART OF THE CONNECTION AND THE TRANSITION AREA OF THE CATHETER HAD ALLEGEDLY TURNED BLACK, WHICH ALLEGEDLY CAUSED THE NARROWING OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766327 ↗
• MalfunctionOct 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PREPARATION OF CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER PERFORATION WAS DISCOVERED DURING DRUG ADMINISTRATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503064 ↗
• InjuryAug 21, 2024Fracture; Material Separation; Expulsion; Fracture; Material Separation; Expulsion

  IT WAS REPORTED THAT SOMETIMES POST A CHRONIC CATHETER PLACEMENT, THE CUFF WAS ALLEGEDLY EXPOSED, SUTURES NOT ADHERENT. IT WAS FURTHER REPORTED THAT THE CATHETER SLID OUT WITHOUT ANY RESISTANCE. REPORTEDLY, THE TIP OF CATHETER WAS SHORT BUT NOT FRAYED, NOT BEVELED. ADDITIONALLY, REMOVED LINE WAS LOOKING SHORT AND SUSPECTED POSSIBILITY OF BROKEN PIECE OF BROVIAC LINE RETAINED AT THE TIME OF LINE REMOVAL. BROKEN PIECE WAS REMOVED BY SURGERY USING INTERVENTIONAL RADIOLOGY. THE PROCEDURE WAS COMPLETED BY REMOVING AND REPLACING THE LINE. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 20023599 ↗
• MalfunctionJun 29, 2024Fracture; Obstruction of Flow; Burst Container or Vessel; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT THREE DAYS POST A CHRONIC CATHETER PLACEMENT, THE TIP OF THE LINE WAS ALLEGEDLY BLOCKED WHICH ALLEGEDLY RESULTED IN RUPTURE OF LINE ON THE INSIDE THE PATIENT. REPORTEDLY, THE LINE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640398 ↗
• MalfunctionMay 23, 2024Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY BLOCKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379402 ↗
• MalfunctionMay 23, 2024Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY BLOCKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379401 ↗
• MalfunctionMay 23, 2024Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY BLOCKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379396 ↗
• MalfunctionMay 23, 2024Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST A CHRONIC CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY BLOCKED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DIFFICULT TO BE FLUSHED. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379395 ↗
• MalfunctionDec 15, 2023Expulsion; Expulsion

  IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF THE ¿JAPANESE SOCIETY OF PEDIATRIC SURGEONS¿ TITLED "COMPLICATIONS AND MANAGEMENT OF CENTRAL VENOUS CATHETERS OF LONG-TERM TOTAL PARENTAL NUTRITION", THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT VIA THE LEFT EXTERNAL JUGULAR VEIN, THE PATIENT ALLEGEDLY EXPERIENCED REDNESS AND SWELLING AT THE CATHETER INSERTION SITE EARLY AFTER THE PLACEMENT. IT WAS FURTHER REPORTED THAT THE CUFF OF THE CATHETER WAS ALLEGEDLY EXPELLED, FOLLOWED BY ACCIDENTAL REMOVAL CAUSED BY NOT FIXED CUFF TO THE PATIENT. FURTHERMORE, THERE WAS NO REPORTED ON TREATMENT FOR THE REDNESS AND SWELLING. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333590 ↗
• MalfunctionDec 15, 2023Expulsion; Expulsion

  IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF THE ¿JAPANESE SOCIETY OF PEDIATRIC SURGEONS¿ TITLED "COMPLICATIONS AND MANAGEMENT OF CENTRAL VENOUS CATHETERS OF LONG-TERM TOTAL PARENTAL NUTRITION", THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT VIA THE RIGHT EXTERNAL JUGULAR VEIN, THE CATHETER WAS ALLEGEDLY REMOVED DUE TO AN ACCIDENTAL REMOVAL CAUSED BY NOT FIXED CUFF TO THE PATIENT. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333588 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST A CHRONIC CATHETER PLACEMENT, THE LINE WAS ALLEGEDLY FOUND TO BE SNAPPED. IT WAS FURTHER REPORTED THAT THE LINE WAS CLAMPED AND THE FLUIDS WERE PAUSED. FURTHERMORE, THE FLUIDS WERE CHANGED TO THE PERIPHERAL VENOUS LINE AND THE END OF THE CATHETER WAS STILL ATTACHED TO THE PATIENT COVERED WITH THE TEGADERM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109373 ↗
• InjurySep 12, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CUFF WAS ALLEGEDLY MISSING AT THE PROXIMAL END OF THE CATHETER. REPORTEDLY, THE DEVICE ALLEGEDLY FELL OUT IN THE NEONATAL INTENSIVE CARE UNIT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 17727508 ↗
• MalfunctionSep 19, 2022Fluid/Blood Leak; Fracture; Material Puncture/Hole; Fluid/Blood Leak; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT SOMETIMES POST PORT PLACEMENT, THE LINE ALLEGEDLY FOUND TO HAVE A LEAK. IT WAS FURTHER REPORTED THAT CATHETER ALLEGEDLY HAD HOLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444388 ↗
• MalfunctionApr 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE TIP OF THE CATHETER WAS ALLEGEDLY DAMAGED DURING INSERTING THE CATHETER OVER THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14070819 ↗
• MalfunctionSep 28, 2021Burst Container or Vessel; Fracture; Burst Container or Vessel; Fracture

  IT WAS REPORTED THAT SOME TIME POST A CATHETER PLACEMENT, A CRACK WAS ALLEGEDLY FOUND ON THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541057 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT AFTER CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKEN AND BLOOD LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305794 ↗
• InjuryJul 14, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY SIX HOURS POST A CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR, THE PATIENT ALLEGEDLY BLED. UPON INSPECTION, THE CATHETER WAS FOUND TO BE CRACKED. THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12164821 ↗
• InjurySep 11, 2020Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST CHRONIC CATHETER IMPLANTATION, THE DEVICE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT PATIENT DEVELOPED EDEMA UNDER THE SKIN AND INFILTRATION OF THE SKIN. THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Edema

  MAUDE report 10520179 ↗
• InjuryJun 5, 2020Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak

  IT WAS REPORTED THAT DAY AFTER POST CATHETER PLACEMENT, THE CENTRAL VENOUS CATHETER ALLEGEDLY LEAKED THE CONTRAST MEDIUM. IT WAS FURTHER REPORTED THAT, IT WAS CRACKED DURING REMOVAL. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Edema

  MAUDE report 10122742 ↗
• InjuryJun 5, 2020Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak

  IT WAS REPORTED THAT DAY AFTER POST CATHETER PLACEMENT, THE CENTRAL VENOUS CATHETER WAS ALLEGEDLY LEAKED THE CONTRAST MEDIUM. IT WAS FURTHER REPORTED THAT THE CUFF WAS CRACKED DURING REMOVAL. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Edema

  MAUDE report 10122381 ↗
• InjuryMay 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED APPROXIMATELY SIX WEEKS POST CHRONIC CATHETER IMPLANTATION THE DEVICE ALLEGEDLY LEAKED. THE PATIENT EXPERIENCED SWELLING AND WAS TREATED WITH ANTIBIOTICS, HOWEVER THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling

  MAUDE report 10084214 ↗
• MalfunctionJan 14, 2020Fluid/Blood Leak; Failure to Infuse; Fluid/Blood Leak; Failure to Infuse

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600040 CHRONIC CATHETER ALLEGEDLY EXPERIENCED SUBCUTANEOUS LEAK WITHOUT EMBOLIZATION AND FAILURE TO INFUSE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586490 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS EVENT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL 0600040 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A SPLIT AND LEAKED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199607 ↗