Dignity® Mid-Sized CT Port MRDP80AMNRecalls & reported problems
Medical Components, Inc. · 8F PLASTIC DIGNITY® MID-SIZED CT PORT W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER · Class 2 · Implant
All models of Dignity Mid-Sized CT Port (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908110296), received between Jun 13, 2017 and Dec 19, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Aspiration Issue” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Aspiration Issue1
- Disconnection1
- Leak/Splash1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2018Disconnection; Disconnection
REMOVING PORT-PORT SEPARATED FROM CATHETER. WAS ABLE TO GRAB THE CATHETER WITH HEMOSTAT AND REMOVE. THE CUFF/COLLAR WAS ADHERED INTO THE TRACT. IT SEPARATED FROM THE PORT AND THE CATHETER. PATIENT HAS TO RETURN TO HAVE A SURGEON DISSECT THE COLLAR FROM THE TRACT 2 WEEKS LATER.
Patient problems: Foreign Body In Patient
MAUDE report 8178651 ↗MalfunctionJun 13, 2017Leak/Splash; Aspiration Issue
PORT WAS PLACED IN PATIENT. ATTEMPTS TO ASPIRATE PORT BEFORE SUTURING FAILED. PORT WAS INJECTED WITH CONTRAST WHICH SHOWED LEAKING FROM THE DEVICE. BODY OF THE PORT WAS THEN REMOVED AND REPLACED WITH A NEW DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6638160 ↗
Other PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR devices
- PowerPort M.R.I., Groshong 9808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 deaths834 reports
- PowerPort ClearVUE 1608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR18 deaths571 reports
- PowerPort ClearVUE 5608062Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR31 deaths542 reports
- PowerPort M.R.I., ChronoFlex 1808000Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR19 deaths513 reports
- PowerPort M.R.I., ChronoFlex 1808060Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall15 deaths383 reports
- PowerPort M.R.I., Groshong 1808560Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR10 deaths304 reports
- PowerPort M.R.I., ChronoFlex 1829500Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR6 deaths197 reports
- BardPort M.R.I. 0602680Bard Access Systems, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 deaths179 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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