BardPort M.R.I. 0603840Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741025822), received between May 8, 2019 and Sep 22, 2021 — classified as 4 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST PORT DEVICE PLACEMENT, LIQUID WAS ALLEGEDLY NOTED TO BE LEAKING SUBCUTANEOUSLY FROM THE CONNECTION OF THE PIPE. IT WAS FURTHER REPORTED THAT SWELLING UNDER THE SKIN AND EXTRAVASATION WAS NOTED ON THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511421 ↗
• InjuryJan 18, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE DEVICE ALLEGEDLY LEAKED DRUG FROM THE DIAPHRAGM. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING DUE TO THE LEAK. THE PORT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 11184397 ↗
• MalfunctionNov 23, 2020Disconnection; Fluid/Blood Leak; Fracture; Stretched; Material Deformation; Disconnection; Fluid/Blood Leak; Fracture; Stretched; Material Deformation

  IT WAS REPORTED THAT POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY DISCONNECTED FROM THE PORT STEM AND HAD A SUBCUTANEOUS LEAKAGE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10883721 ↗
• InjuryFeb 14, 2020Disconnection; Fracture; Migration or Expulsion of Device; Disconnection; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS THREE MONTHS POST PORT DEVICE IMPLANT, THE CATHETER ALLEGEDLY CRACKED AND DISCONNECTED FROM THE PORT STEM. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY MIGRATED TO THE ATRIUM. REPORTEDLY, THE DEVICE WAS REMOVED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 9714886 ↗
• MalfunctionJan 15, 2020Break; Fracture; Material Separation; Dent in Material; Break; Fracture; Material Separation; Dent in Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL 0603840 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592520 ↗
• MalfunctionOct 18, 2019Break; Fracture; Material Separation; Break; Fracture; Material Separation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0603840, IMPLANTABLE PORT, ALLEGEDLY EXPERIENCED A BREAK IN THE CATHETER. THIS INFORMATION WAS OBTAINED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A FIVE YEAR OLD FEMALE PATIENT WITH NO CONSEQUENCES, THE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208942 ↗
• InjuryMay 8, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST PORT PLACEMENT, AN ALLEGED BREAK IN THE PORT WAS IDENTIFIED. REPORTEDLY, A SEGMENT OF THE PORT WAS REMOVED AND A SECOND SEGMENT WAS REMOVED THE FOLLOWING DAY. THE PATIENT WAS STABLE AFTER PROCEDURE.

  Patient problems: Injury

  MAUDE report 8591978 ↗