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CELSITE 5433556Recalls & reported problems

B Braun Interventional Systems, Inc · CELSITE ST305H SM SET PUR 8,5F IV USA · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963594916), received between May 24, 2016 and May 24, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Skin Inflammation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 24, 2016Patient-Device Incompatibility; Patient-Device Incompatibility

    ACCESS PORT IMPLANTED ON (B)(6) 2015. AFTER 6 TREATMENTS OF TAOTERE (100MG/M2), APPARITION OF A SKIN REDNESS ON THE WHOLE LENGTH OF THE TUNNELED CATHETER. BLOOD CULTURE: NEGATIVE. NO INFLAMMATORY REACTION ABOVE THE ACCESS PORT HOUSING.

    Patient problems: Skin Inflammation

    MAUDE report 5675146 ↗

Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices

All PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.