CELSITE 5430425Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963594817), received between Jul 4, 2016 and Dec 22, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2016Material Separation; Material Separation

  PATIENT'S FAMILY CONTACTED B. BRAUN INTERVENTIONAL SYSTEMS TO REPORT THE FRAGMENT OF A PORT CATHETER SEVERING AND MIGRATING TO RIGHT ATRIUM, WHICH WAS SUCCESSFULLY RETRIEVED. PATIENT HAD PORT DUE TO DIAGNOSIS OF CANCER. SHORTLY AFTER DISCHARGE PATIENT FELT LIKE SOMETHING MOVED IN HER CHEST AND BEGAN EXPERIENCING CHEST PAINS. PATIENT RETURNED TO IMPLANTING HOSPITAL AND WAS TOLD THAT PAINS WERE ASSOCIATED WITH PORT "SETTLING IN" AND WAS SENT HOME. CHEST PAINS PERSISTED, PATIENT WENT TO SECOND HOSPITAL WHERE THEY PERFORMED CHEST X-RAY AND DETERMINED A PIECE OF THE PORT CATHETER BROKE OFF AND WENT INTO HEART. CATHETER SEGMENT WAS RETRIEVED PERCUTANEOUSLY THROUGH JUGULAR VEIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 6197787 ↗
• InjuryOct 5, 2016Detachment Of Device Component; Detachment Of Device Component

  ON (B)(6) 2016: IMPLANTATION OF AN ACCESS PORT VIA THE RIGHT SUBCLAVIAN VEIN. THE CORRECT CATHETER CONNECTION WAS CONFIRMED. ON (B)(6) 2016: DURING THE SECOND CHEMOTHERAPY ADMINISTRATION, DISCONNECTION FO THE CATHETER IS NOTED. THE CATHETER WAS REMOVED BY FEMORAL APPROACH DUE TO ITS MIGRATION IN THE VENA CAVA. ON (B)(6) 2016: EXPLANTATION OF THE ACCESS PORT AND PLACEMENT OF A SECOND ONE. REMARK: NO PROBLEM DURING THE ADMINISTRATION OF THE FIRST CHEMOTHERAPY TREATMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5999949 ↗
• InjuryJul 4, 2016Leak/Splash; Leak/Splash

  LEAKAGE OF CHEMOTHERAPY DRUG AROUND THE ACCESS PORT. SURGERY IN EMERGENCY TO REMOVE THE ACCESS PORT SYSTEM.

  Patient problems: No Information

  MAUDE report 5767951 ↗