Pro-Fuse® CT Port MRCTT96801Recalls & reported problems
Medical Components, Inc. · 9.6F PLASTIC Pro-Fuse® CT PORT W/PRE-ATTACHED SILICONE CATHETER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908031430), received between Jul 16, 2021 and Jul 16, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A PORTACATH INSERTED ON THE (B)(6) 2021 UNDER STERILE CONDITIONS IN INTERVENTIONAL RADIOLOGY. IT WAS ACCESSED FOR TREATMENT ON THE (B)(6) 2021 AND A GRIPPER NEEDLE WAS ATTACHED TO DO THIS. THIS WAS DONE AS AN ASEPTIC TECHNIQUE. THE IV MEDICATIONS WERE ADMINISTERED USING ANTT. THIS WAS DONE AS A DAY CASE IN THE (B)(6). SHE PRESENTED TO ED ON (B)(6) 2021 FEELING UNWELL AND WITH A TEMPERATURE. BLOOD CULTURES WERE TAKEN FROM THE DEVICE WHICH GREW STAPHYLOCOCCAL AUREUS. THE DEVICE WAS REMOVED ON (B)(6) 2021 AND THIS SPECIMEN ALSO GREW STAPH AUREUS IN THE LABORATORY SAMPLE. FURTHER ANALYSIS IS IN PROGRESS. THE PATIENT'S CONDITION IMPROVED.
Patient problems: Unspecified Infection
MAUDE report 12179897 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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