Broviac 0600524Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741051814), received between Nov 11, 2015 and May 25, 2022 — classified as 1 death, 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathMay 25, 2022Fluid/Blood Leak; Expulsion; Migration; Fluid/Blood Leak; Expulsion; Migration

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY ERODED OR BEEN DISPLACED. REPORTEDLY, PATIENT EMERGENTLY TRANSFERRED AND CHEST X-RAY REVEALED A NEW LARGE PLEURAL EFFUSION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 14495311 ↗
• MalfunctionJun 16, 2021Disconnection; Fracture; Disconnection; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY BROKE AT THE HUB WHERE THE IV TUBING CONNECTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009261 ↗
• MalfunctionJun 16, 2021Burst Container or Vessel; Stretched; Burst Container or Vessel; Stretched

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY FORMED A BUBBLE AND BURST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009222 ↗
• MalfunctionDec 4, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY HAD A CRACK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10947515 ↗
• InjuryJun 19, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST CHRONIC CATHETER PLACEMENT, THE CATHETER ALLEGEDLY BROKE EXTERNALLY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED BLEEDING FROM THE BROKEN CATHETER. THE CHRONIC CATHETER WAS REMOVED AND REPLACED. THE PATIENT STATUS IS UNKNOWN POST REPLACEMENT.

  Patient problems: Blood Loss; Injury

  MAUDE report 10172764 ↗
• MalfunctionApr 10, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600544 CHRONIC CATHETER ALLEGEDLY EXPERIENCED BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE 7 MONTH OLD MALE WAS 7 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950609 ↗
• MalfunctionOct 17, 2019Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600524 CHRONIC CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203841 ↗
• MalfunctionOct 16, 2019Break; Break

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600524 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200205 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600524 CHRONIC CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE, GENDER, AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199801 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 600524 HICKMAN S/L CATHETERS EXPERIENCED A FLUID LEAK. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE THREE EVENTS, ALL INVOLVED PATIENTS WITH NO REPORTED INJURY. ONE OF THE PATIENTS IS A (B)(6)-MONTH-OLD BOY WEIGHING (B)(6) KGS. HE WAS INVOLVED IN TWO OF THE COMPLAINTS. THE OTHER PATIENT WAS A (B)(6)-MONTH-OLD BOY ALSO WEIGHING (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529794 ↗
• MalfunctionSep 13, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS PLACED AND 11 DAYS LATER THE CATHETER ALLEGEDLY BROKE. THE LINE WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874860 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER IS BREAKING WHERE THE SKINNY AND LARGE TUBING MEET. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853159 ↗
• MalfunctionNov 9, 2017Material Frayed; Out-Of-Box Failure

  PER SALES REP, THE FACILITY REPORTED THAT UPON OPENING THE KIT IT WAS NOTED THAT THE DILATOR WAS FRAYED. THE KIT WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7013736 ↗
• InjurySep 22, 2017Detachment Of Device Component; Entrapment of Device; Migration or Expulsion of Device

  PER MEDWATCH REPORT, THE FACILITY REPORTED A 4.2FR BROVIAC CVC, WHEN REMOVED BY GENTLE TRACTION REMOVAL, ALLOWED FOR THE SILICONE CUFF TO BE RETAINED IN A PEDIATRIC PATIENT. THE CUFF MIGRATED OUT OF THE PATIENT'S SUBCUTANEOUS ANTERIOR CHEST TISSUE WITH ABSCESS FORMATION. THE CUFF HAD TO BE REMOVED SURGICALLY.

  Patient problems: Cyst(s); Device Embedded In Tissue or Plaque; Edema; Inflammation

  MAUDE report 6886750 ↗
• MalfunctionAug 31, 2017Backflow; Fluid/Blood Leak; Fracture

  IT WAS REPORTED BY FACILITY THAT THE PATIENT PRESENTED WITH BROVIAC CATHETER BLEEDING BACK. MOTHER AND HOME HEALTH RN REPORTED THE CATHETER WAS FRACTURED AND ACTIVELY LEAKING FROM THE TUBING. MOM CLAMPED THE BROVIAC IN THE AREA SHE THOUGHT WAS WHERE THE CATHETER WAS LEAKING AND CAME TO DCMC FOR EVALUATION.

  Patient problems: Blood Loss

  MAUDE report 6834009 ↗
• MalfunctionAug 17, 2017Break; Difficult to Flush; Hole In Material; Material Twisted/Bent

  IT WAS REPORTED BY THE FACILITY THAT ON (B)(6) 2017 THE SURGERY TEAM WAS NOTIFIED BY RN OF CONCERN THAT BROVIAC LINE HAS NOT BEEN WORKING WELL FOR THE PAST TWO DAYS. SHE REPORTS THE LINE HAS BEEN INFUSING CONTINUOUS IV FLUIDS SINCE ADMISSION ON (B)(6) BUT SHE WAS TOLD IN REPORT THAT THE LINE HAS BEEN DIFFICULT TO FLUSH. SHE WAS ALSO TOLD IN REPORT THAT WHEN THE DRESSING WAS CHANGED THAT DAY, THE LINE TUBING LOOKED LIKE "THE TUBING IS BREAKING". MOTHER REPORTED SHE HAS BEEN CHANGING DRESSINGS ONCE A WEEK AT HOME WHEN THEY HAVE NOT BEEN IN THE HOSPITAL SINCE THE LINE WAS PLACED AND REPORTS THAT THE TUBING HAS NOT CHANGED AND HAS HAD NO DIFFICULTY FLUSHING. HOWEVER, MOTHER FEELS THE TUBING LOOKED "TWISTED" TODAY WHEN SHE SAW IT DURING THE DRESSING CHANGE BY THE BEDSIDE NURSE AND SAYS IT LOOKS LIKE IT MAY HAVE "PULLED OUT A LITTLE". AT THAT TIME, IT WAS NOTED THAT THERE WAS A HOLE IN THE OUTER SHEALTH OF THE BROVIAC RIGHT WHERE THE SKINNY TUBING TURN INTO THE FAT TUBING DISTALLY, BUT IT WAS NOT LEAKING AND A FLURO STUDY SHOWED THERE WAS NO LEAK. SHE WAS THEN SCHEDULED FOR REMOVAL OF BROVIAC AND REPLACEMENT OF BROVIAC/PORT A WEEK LATER AFTER HER COUNTS RECOVERED FROM CHEMO, BUT THE LINE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6800384 ↗
• MalfunctionNov 11, 2015Fracture

  ON (B)(6) 2015 REPORTEDLY, ON (B)(6) 2014, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ALLEGEDLY, WITH A MALFUNCTIONING CATHETER. HE WAS SENT BACK TO REHABILITATION TO SCHEDULE AN APPOINTMENT WITH INTERVENTIONAL RADIOLOGY. THE PATIENT CAME BACK TO INTERVENTIONAL RADIOLOGY ON (B)(6) 2014 TO REMOVE THE ALLEGED MALFUNCTIONING BROVIAC AND REPORTEDLY, A PICC LINE WAS INSERTED FOR THE PATIENTS LONG TERM ANTIBIOTIC TREATMENT. AS PER (B)(6) 2014 EMAIL FROM THE DOCTOR WHO PLACED IT, THE CATHETER HAD ALLEGEDLY, FRACTURED.

  Patient problems: No Code Available

  MAUDE report 5218185 ↗