PowerPICC Provena SOLO S1395108D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741154812), received between Sep 13, 2019 and May 20, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "THEIR PICC NURSE WAS HAVING ISSUES WITH THE GUIDEWIRE AND IT NOT THREADING INTO THE VESSEL WITH THEIR 5FR TRIPLE LUMEN PICC KIT. SHE WAS ABLE TO GET BLOOD RETURN OUT OF THE NEEDLE BUT WHEN SHE WENT TO ADVANCE THE GUIDEWIRE IT JUST KEPT COILING AROUND IN THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461994 ↗
• InjuryJul 9, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED VIA MEDWATCH "PATIENT'S BRACHIAL VESSEL WAS ACCESSED USING THE SAFETY NEEDLE SUPPLIED IN THE BARD PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) KIT. BLOOD RETURN FROM THE NEEDLE WAS POSITIVE AND THE GUIDEWIRE WAS INTRODUCED THROUGH THE NEEDLE. THE NEEDLE WAS THEN REMOVED FROM THE PATIENT'S VESSEL, LEAVING THE GUIDEWIRE IN PLACE. I THEN MADE A TINY INCISION RIGHT ABOVE THE GUIDEWIRE TO ALLOW THE DILATOR/INTRODUCER TO BE PLACED. I THREADED THE GUIDEWIRE INTO THE NEEDLE INTRODUCER AND BEGAN TO APPLY PRESSURE TO ADVANCE THE INTRODUCER INTO THE VESSEL. AS I CONTINUED TO APPLY PRESSURE TO THE INTRODUCER, THE GUIDEWIRE ADVANCED INTO THE VESSEL AS WELL. I REMOVED THE ENTIRE INTRODUCER SINCE I DIDN'T SEE THE WIRE, AND WAS UNABLE TO SEE THE GUIDEWIRE. I APPLIED PRESSURE TO STOP THE BLEEDING AND THEN ULTRASOUND THE PATIENT'S AREA TO CONFIRM THE WIRE WAS IN FACT IN THE PATIENT'S VASCULATURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 12144192 ↗
• MalfunctionFeb 9, 2021Material Frayed; Material Twisted/Bent

  IT WAS REPORTED PICC PLACED ON RIGHT UPPER EXTREMITY DIFFICULTY GETTING LINE TO DROP PAST SHOULDER, APPEARING TO COIL AT TIP OF CATHETER, SO LINE WAS REMOVED AND INSPECTED. 3CG WIRE WAS NEVER TAKEN OUT AND RE-ADVANCED BACK THROUGH PICC CATHETER DURING PLACEMENT ATTEMPT. 3CG WIRE NOTED TO BE BENT, ALMOST FRACTURED OFF 1CM FROM DISTAL TIP. ADDITIONAL INFORMATION RECEIVED 01/21/2021: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: CATHETER WAS REMOVED AFTER PLACEMENT ATTEMPT AND BENT WIRE NOTED. NO SECUREMENT DEVICE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11305143 ↗
• MalfunctionSep 13, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE VALVED HUB BROKE OFF OF THE EXTENSION LEG ON A PICC. 9/05/2019- ADDITIONAL INFORMATION FROM FACILITY STATED, "PATIENT WAS BEING MOVED IN BED VERY LITTLE TENSION ON IV TUBING AND THE CAP DISCONNECTED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035890 ↗