DIGNITY® CT PORT MRDP95ADSRecalls & reported problems
Medical Components, Inc. · 9.5F PLASTIC DIGNITY® DUAL CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE CHRONOFLEX® POLYRURETHANE CATHETER · 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 00884908115567), received between Jun 18, 2021 and Jun 18, 2021 — 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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2021Leak/Splash; Leak/Splash
PATIENT PRESENTED TO HAVE CADD (COMPUTER-AIDED DRUG DISCOVERY) PUMP CHANGED. DIFFICULT BLOOD RETURN NOTED. SUPERIOR PORT SITE LEAKING. PORT WAS FLUSHED, DE-ACCESSED. ACCESSED INFERIOR LUMEN AND CONNECTED PUMP. ADDITIONAL INFORMATION PROVIDED BY RISK MANAGER: "DURING VISIT, THE SUPERIOR PORT SITE WAS SLIGHTLY REDDENED. SHE WAS INSTRUCTED TO GO TO THE ED IF IT GOT WORSE. THE FOLLOWING DAY, SHE WENT TO ED WITH INCREASED REDDENING AND GIVEN A COURSE OF ANTIBIOTICS FOR POSSIBLE PORT SITE INFECTION. PATIENT CONTINUES TO RECEIVED HER TREATMENTS USING THE LATERAL PORT."
Patient problems: Swelling/ Edema
MAUDE report 12023805 ↗
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 13, 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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