PowerPICC Provena S1193108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741155185), received between Jan 6, 2021 and Sep 25, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 reports).

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-2664-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PICC WAS SUCCESSFULLY PLACED. WHEN RN WENT TO FLUSH THE SIDE PORT, SALINE WAS LEAKING OUT OF THE PRN ADAPTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301967 ↗
• InjuryJul 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CUSTOMER REPORTED "THERE HAS BEEN A PATIENT EVENT WITH HARM DUE TO INADVERTENT ARTERIAL PICC PLACEMENT. WE WOULD LIKE BD TO ADDRESS WHY THE SHERLOCK/3CG TECHNOLOGY WOULD SHOW AN INCREASE IN P-WAVE AMPLITUDE TO INDICATE THAT THE TIP WAS IN THE CORRECT POSITION, EVEN IF THE PICC WAS ACTUALLY IN THE ARTERIAL SYSTEM. IN THE PATIENT EVENT WHEN 3CG TECHNOLOGY WAS USED TO CONFIRM PROPER PICC TIP PLACEMENT, THE ECG STRIPS MET CRITERIA FOR RELEASING THE PICC FOR USE. THE PICC WAS LATER CONFIRMED BY OTHER MEASURES TO BE ARTERIAL INSTEAD OF VENOUS. THE SITUATION HAS BEEN EXTENSIVELY REVIEWED VIA OUR INSTITUTIONAL QUALITY AND PATIENT SAFETY PROCESS. PICC RNS HAVE RECEIVED REFRESHER EDUCATION AND OPPORTUNITIES TO ENHANCE PATIENT SAFETY ARE BEING EXPLORED."

  Patient problems: Embolism/Embolus; Stroke/CVA

  MAUDE report 17330939 ↗
• InjuryJul 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER, "PATIENT EVENT WITH HARM DUE TO INADVERTENT ARTERIAL PICC PLACEMENTS. SHERLOCK/3CG TECHNOLOGY WOULD SHOW AN INCREASE IN P-WAVE AMPLITUDE TO INDICATE THAT THE TIP WAS IN THE CORRECT POSITION, EVEN IF THE PICC WAS ACTUALLY IN THE ARTERIAL SYSTEM. IN THIS PATIENT EVENT WHEN 3CG TECHNOLOGY WAS USED TO CONFIRM PROPER PICC TIP PLACEMENT, THE ECG STRIPS MET CRITERIA FOR RELEASING THE PICC FOR USE. THESE PICC WAS LATER CONFIRMED BY OTHER MEASURES TO BE ARTERIAL INSTEAD OF VENOUS." PICC INSERTED (B)(6)2023 WITH ECG TIP CONFIRMATION. PICC REMOVED BY VASCULAR SURGERY.

  Patient problems: Stroke/CVA

  MAUDE report 17305231 ↗
• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE CUSTOMER THAT THE "ECG WIRE BENT WITHIN PICC LINE." ADDITIONAL INFORMATION 01/24/2023: IT WAS REPORTED BY THE CUSTOMER "HAD TO OPEN A NEW PROVENA PICC KIT DUE TO MALFUNCTIONS OF LINE. PICC LINE NEVER TOUCHED THE PATIENT." (B)(6)2023: THE RETURNED DEVICE WAS CONFIRMED TO BE A BENT STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921586 ↗
• MalfunctionApr 4, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "WHILE PLACING PICC LINE DILATOR IT WAS DIFFICULT TO ADVANCE AND CAUSING DISCOMFORT BEYOND WHAT IS EXPECTED DURING THE PROCEDURE. PROCEDURE WAS HALTED, DILATOR REMOVED AND INSPECTED. IT WAS NOTED THE DILATOR HAD BENT BACK AT THE TAPER AT THE POINT OF INSERTION. THIS CAUSED THE DILATOR NOT TO ADVANCE AND CAUSE INCREASED PAIN. A NEW KIT WAS BROUGHT TO THE BEDSIDE AND PICC WAS SUCCESSFULLY PLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678948 ↗
• MalfunctionMar 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MS&S: "CALLER STATES HER MOM HAS A POWERPICC PROVENA SOLO. SHE STATES WHEN SHE OR THE NURSE FLUSH THE PICC THEY HEAR A WHISTLING SOUND AROUND THE ROUND PORTION OF THE CATHETER HUB. CALLER STATES THERE IS NO SIGN OF LIQUID LEAKING WHEN THEY FLUSH ONLY THE SOUND OF AIR ESCAPING." MS&S RESPONSE: "INFORMED CALLER THAT THEY SHOULD DISCONTINUE USE OF THE CATHETER AND HAVE IT EVALUATED BY A DOCTOR AS SOON AS POSSIBLE. THE RISK OF BLEEDING AND INFECTION IF THERE IS A HOLE IN THE CATHETER IS POSSIBLE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16562378 ↗
• MalfunctionJan 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "INTRODUCER PEALED BACK UPON INSERTION ATTEMPT AND ECG WIRE BENT WITHIN PICC LINE". ADDITIONAL INFORMATION 01/24/2023: IT WAS REPORTED BY THE CUSTOMER "HAD TO OPEN A NEW PROVEN A PICC KIT DUE TO MALFUNCTIONS OF LINE. PICC LINE NEVER TOUCHED THE PATIENT, BUT INITIAL INTRODUCER DID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275131 ↗
• MalfunctionNov 4, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER "WIRE WAS HAIRY" ADDITIONAL INFORMATION RECEIVED 10/28/2022: WAS THERE ANY PATIENT HARM REPORTED? NO WHAT THEY¿RE BEING TREATED FOR: MDR KLEBSIELLA UTI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736687 ↗
• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "UNABLE TO ADVANCE MICROINTRODUCER INSIDE THE VEIN, SHEARING ON THE "GRAY" PART OF THE MICROINTRODUCER." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458232 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE FACILITY IS EXPERIENCING WIRES KINKING LATELY, ALMOST TO THE "BREAKING POINT". NO OTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579054 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THE FACILITY IS EXPERIENCING WIRES KINKING LATELY, ALMOST TO THE "BREAKING POINT". NO OTHER EVENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578930 ↗
• MalfunctionJan 6, 2021Volume Accuracy Problem

  IT WAS REPORTED "WE ARE HAVING SO MUCH TROUBLE WITH 3 FR SINGLE LUMEN PICCS. IT HAS BEEN OFF THE ACCURACY WITH THE SHERLOCK SEVERAL TIMES (PERFECT ECG GRAPHICS, BUT UPPER SVC OR BRACHIOCEPHALIC VEIN IN CHEST X-RAYS)." IT WAS STATED THIS OCCURRED TWICE. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11125071 ↗
• MalfunctionJan 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Delivery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED "WE ARE HAVING SO MUCH TROUBLE WITH 3 FR SINGLE LUMEN PICCS. IT HAS BEEN OFF THE ACCURACY WITH THE SHERLOCK SEVERAL TIMES (PERFECT ECG GRAPHICS, BUT UPPER SVC OR BRACHIOCEPHALIC VEIN IN CHEST X-RAYS)." IT WAS STATED THIS OCCURRED TWICE. THIS REPORT ADDRESSES THE FIRST EVENT.

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

  MAUDE report 11125044 ↗