DIGNITY® CT PORT MIDP95ADSRecalls & reported problems
Medical Components, Inc. · 9.5F PLASTIC DIGNITY® DUAL CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER W/5F MICRO-STICK® INTRODUCER SET · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908115475), received between Jan 25, 2024 and Jan 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2024Leak/Splash; Leak/Splash
(B)(6) 2024 PATIENT RESENTED W/ CP/SOB, CT CHEST ORDERED AFTER DUAL PORT ACCESSED, FELT POPPING SENSATION W/ INJECTION- OF CONTRAST, IMAGING W/ CONTRAST IN LEFT CHEST SQ TISSUE, EVALUATED BY RADIOLOGIST AND CONFIRMED NEEDLE PLACEMENT AND BLOOD RETURN. PORT DE-ACCESSED D/T PAIN/ EDEMA AROUND PORT POCKED. RE-ACCESSED ON (B)(6) 2024 W/TISSUE DISPLACEMENT W/ FLUSHING UPPER LUMEN VIA HUBER NEEDLE. (B)(6) 2024 PROCEDURE EXCHANGE. PORT BODY ON THE BACK TABLE: ACCESSED UPPER PORT W/ BULGING OF THE RESERVOIR AND LEAKING OF SALINE ON THE UNDERSIDE OF THE PORT BODY.
Patient problems: Pain; Swelling/ Edema
MAUDE report 18579267 ↗
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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