Port Access Kit 2652034Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741044472), received between May 24, 2018 and Feb 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS RUNNING 24-HOUR METHOTREXATE AND WAS APPROXIMATELY 20 HOURS INTO INFUSION (WITH SODIUM BICARBONATE FLUIDS RUNNING AT THE SAME TIME). PARENT PRESSED CALL LIGHT AND REPORTED THAT THE PATIENT'S IMPLANTED PORT WAS HURTING HER. RN PAUSED METHOTREXATE AND SODIUM BICARBONATE AND ASSESSED THE PORT SITE. THE DRESSING WAS TAUGHT DUE TO LOCALIZED EDEMA AT THE SITE, AND THE PATIENT'S SHIRT WAS WET OVER THE SITE. IT WAS SUSPECTED TO BE INFILTRATED AND THE PROVIDER CAME AND ASSESSED AND AGREED. PORT WAS DE-ACCESSED AND HEAT WAS APPLIED TO THE SITE.

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 24337635 ↗
• MalfunctionApr 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT BARD PORT ACCESS KITS TEGADERM DO NOT STICK TO PATIENT SKIN TO PREVENT INFECTION. IN FACT IT IS NOT SECURELY ADHERED TO THE PACKAGING EITHER. THIS IS ALL THE KITS, REQUIRING USING A #M TEGADERM. LOT NUMBER IS REHY1908. THERE WAS NOT ANY PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184429 ↗
• MalfunctionJun 13, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE CUSTOMER THAT, "TAPE IS NOT STICKING WELL TO THE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17122265 ↗
• MalfunctionMay 21, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THE SAFETY INFUSION SET NEEDLES DIDN'T RETRACTED WHEN REMOVED FROM THE PATIENTS, CAUSING A SAFETY RISK TO THE INFUSION NURSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11865841 ↗
• MalfunctionMay 24, 2018Out-Of-Box Failure

  IT WAS REPORTED THAT THE CHLORAPREP APPLICATOR WAS COMPLETELY EMPTY WHEN IT WAS REMOVED FROM THE PORT ACCESS KIT DURING THE PLACEMENT PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7541049 ↗