Dignity Low Profile CT PortRecalls & reported problems across all models

We found 4 models of Dignity Low Profile CT Port by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2017 and Apr 22, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Dignity Low Profile CT Port recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 22, 2017Terminated

   The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

   Z-1271-2018 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Most reported Dignity Low Profile CT Port problems

Dignity Low Profile CT Port models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dignity® Low Profile CT Port MRDP80PLN

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Dignity® Low Profile CT Port MRCTI66041

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Dignity® Low Profile CT Port MIDP80ALS

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Dignity® Low Profile CT Port MRDP80ALN

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report

Recent Dignity Low Profile CT Port adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2021Leak/Splash; Leak/Splash

  THE CONTRAST MEDIUM INJECTED INTO THE RESERVOIR SHOWED LEAKAGE JUST IN THE PROXIMAL PORTION ADJACENT TO IT IN THE PECTORAL REGION, AN UPPER PATH APPARENTLY EXTERNAL TO THE CATHETER WAS ALSO OBSERVED, WITH A GREATER QUANTITY FLOWING TO THE CERVICAL REGION. THESE FINDINGS SUGGEST IMPAIRMENT OF THE RESERVOIR OR EVEN THE PROXIMAL PORTION OF THE CATHETER, WHICH MAY BE RELATED TO OBSTRUCTION, FRACTURE OR EVEN DISCONNECTION.

  Patient problems: Insufficient Information

  MAUDE report 11709637 ↗
• MalfunctionMar 22, 2019Leak/Splash; Leak/Splash

  X-RAY REVEALED EXTRAVASATION OF CONTRAST AROUND THE DRUM DURING INFUSION.

  Patient problems: Extravasation

  MAUDE report 8445184 ↗
• InjuryDec 7, 2017Break; Break

  PORT NOTED TO BE MALFUNCTIONING. CHEST X-RAY SHOWED A DENSE LINEAR STRUCTURE WITHIN THE PORT CATHETER (GREEN WIRE).

  Patient problems: Foreign Body In Patient

  MAUDE report 7095869 ↗
• MalfunctionApr 17, 2017Detachment Of Device Component

  PORT DETACHED FROM CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6496916 ↗

Other Medical Components, Inc. products

• VASCU-PICC22 models · 129 reports
• DIGNITY10 models · 12 reports · 1 recall
• Dignity Mid-Sized CT Port4 models · 4 reports · 1 recall
• Hemo-Cath10 models · 42 reports
• SLX Hemo-Cath4 models · 32 reports
• Pro-PICC CT12 models · 31 reports
• Split Cath III14 models · 26 reports