PICC Prime PFM2CT5TRecalls & reported problems
Pfm Medical Incorporated · 5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813623013780), received between Sep 14, 2018 and Oct 30, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- Discomfort1
- 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.
MalfunctionOct 30, 2018Fracture; Fracture
A LEAK WAS OBSERVED COMING FROM THE "RED HUB" LUER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8020778 ↗MalfunctionSep 14, 2018Fracture; Fracture
THE PICC WAS INITIALLY PLACED ON (B)(6) 2018. THREE DAYS LATER THE NURSE WAS CALLED BY THE INFUSION CENTER TO REPLACE THE PICC DUE TO LEAKAGE COMING FROM THE "RED HUB"(LUER FITTING). IT WAS STATED THAT THE "RED HUB" WAS NOT CRACKED BUT RATHER DESCRIBED AS HAVING A HOLE. THE PICC WAS REPLACED.
Patient problems: Discomfort
MAUDE report 7879161 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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