Dignity® Mini CT Port MICTI50041MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884908089639), received between Feb 23, 2021 and Jan 18, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionJan 18, 2024Leak/Splash; Leak/Splash

  PATIENT WITH DIGNITY 5F PORT ON THE RIGHT ARM UNDERGOING TREATMENT WITH ANTICANCER CHEMOTHERAPY. AS EXTRAVASATION DUE TO CATHETER INJURY IS SUSPECTED, THE DEVICE IS REMOVED AND A PARTIAL CATHETER INJURY IS FOUND, APPROXIMATELY 6-7CM FORM THE CONNECTION BETWEEN RESERVOIR AND CATHETER.

  Patient problems: Extravasation

  MAUDE report 18536119 ↗
• MalfunctionDec 13, 2023Break; Leak/Splash; Break; Leak/Splash

  DURING SCHEDULED IRRIGATION WITH SALINE SOLUTION OF THE PORT, SWELLING OF THE SUBCUTANEOUS TISSUE APPEARS DUE TO SUSPECTED EXTRAVASATION. AFTER THE X-RAY VERIFICATION OF THE INTEGRITY OF THE CATHETER IN THE THORACIC AND BRACHIAL TRACT, THE DEVICE WAS REMOVED WITH ALMOST TOTAL BREAKAGE DETECTED 2 CM FROM THE RESERVOIR IN THE SUBCUTANEOUS SECTION OF THE CATHETER WITH ANOTHER SMALL LESION 0.5 CM FROM THE PREVIOUS ONE. DEVICE WAS IMPLANTED (B)(6) 2021. NO PROBLEMS WITH THE DEVICE DURING PREVIOUS ADMINISTRATIONS OF ANTI-TUMOR THERAPY. USE SUSPENDED FOR MORE THAN ONE YEAR PRIOR TO THIS EVENT.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 18319301 ↗
• InjuryAug 8, 2023Break; Break

  PATIENT WITH PICC-PORT ON RIGHT ARM, PLACED IS 2019, NOT USED ANYMORE. PATIENT UNDERGO DEVICE REMOVAL FOR END-THERAPY. DURING PORT RESERVOIR REMOVAL, A COMPLETE LESION OF CATHETER WAS FOUND APPROX. 4 CM FROM PORT CONNECTOR. THE DISTAL FRAGMENT OF THE CATHETER IS NOT IDENTIFIABLE WITHIN THE SURGICAL INCISION. AN INTRAPROCEDURAL ULTRASOUND EXAMINATION SHOWS THE CATHETER INSIDE THE AXILLARY VEIN, IN CORRESPONDENCE WITH THE AXILLARY CAVITY, IN A POSITION THAT CANNOT BE REACHED BY SURGICAL ACCESS. THE ULTRASOUND EXAMINATION ALSO ALLOWS TO EXCLUDE THE PRESENCE OF THE FRAGMENT IN AN EXTRAVASCULAR SITE. IT WAS THEREFORE DECIDED TO CLOSE THE SKIN WITH INTRADERMAL STITCHED AND CYANOACRYLATE GLUE, AFTER HAVING REMOVED THE RESERVOIR AND THE PROXIMAL FRAGMENT. THE DISTAL FRAGMENT WILL BE REMOVED BY INTERVENTIONAL RADIOLOGIST, PROCEDURE PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481158 ↗
• MalfunctionAug 8, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DURING SCHEDULED REMOVAL OF THE DEVICE FOR END OF USE, IT IS NOTED THAT THE PORT CATHETER IS DAMAGED 2-3CM FROM THE PORT RESERVOIR, NOT YET FRACTURED/EMBOLIZED. THE DEVICE WAS REMOVED WITHOUT FURTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481017 ↗
• MalfunctionJul 14, 2023Break; Break

  UPON REMOVAL OF THE CATHETER, IN AN EPISODE OF EXTRAVASATION, WITH DIFFUSE EDEMA IN THE DORSAL REGION OF THE ARM FOUND ON ULTRASOUND, THERE WAS AN ALMOST COMPLETE LESION OF THE CATHETER OF ABOUT 4 CM FROM THE INSERTION WITH THE PORT CONNECTOR.

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 17325152 ↗
• MalfunctionNov 28, 2022Break; Flushing Problem; Infusion or Flow Problem; Break; Flushing Problem; Infusion or Flow Problem

  DEVICE USED FOR CHEMOTHERAPY. DEVICE NOT WORKING IN ASPIRATION AND INFUSION. UPON REMOVAL THERE IS KINKING OF THE CATHETER BODY 4 CM FROM THE HUB TO THE CHAMBER. ALSO PRESENCE OF CRACKS IN THE BODY AND IN THE CONNECTION POINT ON THE RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869096 ↗
• InjuryFeb 23, 2021Break; Break

  DEVICE INSERTED (B)(6) 2018 AND USED FOR TREATMENT AND NEVER REMOVED ONCE CHEMO THERAPY ENDED. THE DEVICE WAS REGULARLY MAINTAINED WITH A PERIODIC LOCK. DURING THE LAST CHECK THE OPERATOR NOTED ASPIRATION DEFECT AND SUBCUTANEOUS SUBCLAVICULAR EDEMA UPON INJECTION OF SOLUTION. CHEST X-RAY SHOWED A CLEAN BREAK OF THE CATHETER WITH MIGRATION TO RIGHT HEART CHAMBERS WITH TIP END LOCATED IN PULMONARY ARTERY MAIN TRUNK. NO SIGNS OF CARDIAC IRRITATION-NORMAL SINUS RHYTHM, NORMAL HEART RATE AND BLOOD PRESSURE. EMBOLIZED CATHETER REMOVED WITH INTERVENTIONAL RADIOLOGY PROCEDURE. PATIENT DISCHARGED THE FOLLOWING DAY.

  Patient problems: Infiltration into Tissue

  MAUDE report 11364649 ↗