Pro-PICC® CT MR17034105Recalls & reported problems
Medical Components, Inc. · 4F X 55CM SINGLE LUMEN Pro-Picc® CT BASIC NURSING SET · Class 2 · Implant
All models of Pro-PICC CT (12)
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 00884908033083), received between Jan 3, 2023 and Jan 3, 2023 — 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2023Leak/Splash; Leak/Splash
PATIENT SENT TO PICC TEAM BECAUSE DEVICE DID NOT ASPIRATE AND PATIENT EXPLAINED INFUSION PAIN ASSOCIATED WITH ARM EDEMA. UPON OBSERVATION THE PICC DOES NOT ASPIRATE AND INFUSES WITH RESISTANCE. ULTRASOUND SHOWS COMPRESSIBLE VEIN SO DEVICE WAS REMOVED. AFTER REMOVAL A KINK AND CRACK WAS FOUND ABOUT 10CM FROM THE EXIT SITE.
Patient problems: Pain
MAUDE report 16086326 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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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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