PowerPICC Provena S1385108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741155178), received between Dec 21, 2018 and Sep 30, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  It was reported that an ICU patient with a triple-lumen PICC came back from having a CT with contrast and the RN noted a cracked line. The catheter was removed and replaced. No other information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941797 ↗
• MalfunctionMay 28, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE STERILE PICC KIT. USER HAD TO OPEN A NEW PICC KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321892 ↗
• MalfunctionApr 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED (B)(6) 2025 @ 1730 - LUE TRIPLE LUMEN PICC PLACED - CONFIRMED CAVOATRIAL JUNCTION WITH SHERLOCK 3CG. PICC TOTAL LENGTH: 44CM, EXTERNAL MARKING: 0CM. (B)(6) 2025 @ 1336 - CT ANGIO PULMONARY INCL POST PROCESSING PERFORMED; IMAGE CAPTURED DURING STUDY SHOWING PICC TIP STILL CAVOATRIAL JUNCTION. (B)(6) 2025 @ 0611 - CHEST 1 VIEW SHOWS PICC MALPOSITION. CTA PULMONARY STUDY PERFORMED INJECTED AT 4ML/SEC. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780540 ↗
• MalfunctionApr 2, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2026, A RIGHT UPPER EXTREMITY TRIPLE LUMEN PICC WAS PLACED. TIP CONFIRMATION WITH SHERLOCK 3CG WAS UNSUCCESSFUL DUE TO THE PATIENT BEING IN ATRIAL FIBRILLATION. A CHEST XRAY WAS SUBSEQUENTLY ORDERED, WHICH INITIALLY DEMONSTRATED THE PICC TIP TERMINATING AT THE CAVOATRIAL JUNCTION. THE PICC HAD A TOTAL CATHETER LENGTH OF 43 CM WITH AN EXTERNAL MARKING OF 0 CM. THE PATIENT LATER UNDERWENT A CT OF THE ABDOMEN AND PELVIS WITH CONTRAST. A SUBSEQUENT CHEST XRAY REVEALED MALPOSITION OF THE PICC TIP. PER THE CT DEPARTMENT, THE STUDY WAS PERFORMED USING AN INJECTION RATE OF 4 ML PER SEC. THE PROVIDER APPROVED ADMINISTRATION OF AN ADDITIONAL DOSE OF CONTRAST, AS IT APPEARED THE PATIENT FIRST UNDERWENT A ROUTINE ABDOMINAL PELVIC STUDY AND THEN REQUIRED A TRUE ARTERIAL STUDY. THE ABDOMINAL PELVIC CT WAS INJECTED AT 2.5 ML PER SEC THROUGH THE PICC LINE, WHICH SHOULD NOT HAVE CAUSED DISRUPTION OF THE CATHETER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769426 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE IS A PIN SIZE HOLE IN THE CATHETER WHERE MEDICATION LEAKED OUT. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238095 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED, PICC WAS PLACED ON (B)(6) 2025, DRESSING WAS DUE TO BE CHANGED. WHEN WE ARRIVED IN THE PATIENT'S ROOM, THE ORIGINAL DRESSING FROM (B)(6) WAS INTACT, BUT ONE LUMEN OF THE PICC WAS MISSING. PATIENT HAS NO RECOLLECTION OF ANYTHING HAPPENING WITH PICC LINE. NURSE ON DUTY WAS UNAWARE AS WELL; THIS NURSE HAD NOT HAD PATIENT PREVIOUSLY. PICC WAS REMOVED IMMEDIATELY. ON INSPECTION, LUMEN LOOKS TO HAVE BEEN PULLED OUT. IT DOES NOT LOOK TO HAVE BEEN CUT IN ANY WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843259 ↗
• MalfunctionOct 22, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY MEDWATCH INTRAVENOUS THROMBOLYSIS (IVT) PLACING PICC TO RUE PER MEDICAL DOCTOR (MD) ORDER. THE PROCEDURE PROGRESSED AS EXPECTED UNTIL IT WAS TIME TO "BREAK" THE PEEL AWAY SHEATH OF THE INTRODUCER. UPON CRACKING THE CONNECTOR OF THE PEEL AWAY SHEATH, ONE RED HALF (LEFT) STAYED ATTACHED TO THE GRAY PEEL AWAY HALF, BUT THE RIGHT HALF OF THE RED PORTION FELL OFF IN THE REGISTERED NURSE (RN)'S HAND. THE ONLY WAY TO PEEL THE SHEATH APART WAS TO MANUALLY PLUCK THE GRAY PEEL AWAY PORTION FROM THE PICC AND TEAR IT TO REMOVE (COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATION TO THE PATIENT). THE PICC COMPLETED IN EXPECTED FASHION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357697 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED A REPORT WHERE THE INTRODUCER WAS FOUND TO BE FRAYED AT THE BASE CAUSING PICC VESSEL TO BLOW. THIS WAS NOT IDENTIFIED UNTIL AFTER THE ATTEMPT WAS COMPLETED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682541 ↗
• MalfunctionJul 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED CLINICIAN PLACED A PICC IN THE PATIENT AND THEY DEVELOPED AN INTERNAL KINK IN THE MED UPPER LEFT ARM. PLACED ON (B)(6) 2025, KINK NOTED ON (B)(6) 2025, KINK NOTED ON HUMERUS FILM AFTER SUSPECTED KINK. THE PATIENT WAS IN THE ICU AND NEEDED CENTRAL ACCESS SO THE ICU TEAM HAD TO PLACE AN IJ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669430 ↗
• MalfunctionMar 7, 2025Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDSUN THAT WHILE PERFORMING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACEMENT, WHEN REGISTERED NURSE (RN) DEPLOYED SAFETY DEVICE FOR THE 21 GAUGE ACCESS NEEDLE, THE GREEN PIECE CAME RIGHT OFF. HEALTHCARE PROVIDER KEPT UNCOVERED USED DIRTY NEEDLE AWAY FROM OTHER EQUIPMENT PIECES ON TRAY SO AS NOT TO HAVE AN ACCIDENTAL NEEDLE STICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551263 ↗
• MalfunctionFeb 20, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN RN OPENED THE PICC KIT, IT WAS FOUND THAT THE NEEDLE FOR LIDOCAINE INJECTION WAS BENT (DAMAGED AND NOT FUNCTIONAL). THEN WHEN RN DEPLOYED THE NEEDLE SAFETY DEVICE FOR THE 21 G ACCESS NEEDLE, THE GREEN PIECE CAME RIGHT OFF AND THE SAFETY FEATURE FOR THE ACCESS NEEDLE WOULD NOT DEPLOY. RN WAS ABLE TO USE AN ALTERNATIVE NEEDLE FOR LIDOCAINE INJECTION, AND KEPT THE UNCOVERED USED DIRTY NEEDLE AWAY FROM HER OTHER EQUIPMENT PIECES ON TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421467 ↗
• MalfunctionFeb 18, 2025

  WHILE PERFORMING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACEMENT, NEEDLE FOR LIDOCAINE INJECTION IN THE PICC LINE KIT WAS DAMAGED AND NOT FUNCTIONAL (COMPLETELY BENT). THEN WHEN REGISTERED NURSE (RN) DEPLOYED SAFETY DEVICE FOR THE 21 GAUGE ACCESS NEEDLE, THE GREEN PIECE CAME RIGHT OFF. RN WAS ABLE TO USE AN ALTERNATIVE NEEDLE FOR LIDOCAINE INJECTION. HEALTHCARE PROVIDER KEPT UNCOVERED USED DIRTY NEEDLE AWAY FROM OTHER EQUIPMENT PIECES ON TRAY SO AS NOT TO HAVE AN ACCIDENTAL NEEDLE STICK. HEALTHCARE PROVIDER KEPT NON-FUNCTIONING/DAMAGE PIECES FOR ANALYSIS, NOTIFIED BARD REPRESENTATIVE, WHO PLACED AN INCIDENT REPORT WITH BARD, AND RISK DEPARTMENT NOTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 21392084 ↗
• MalfunctionJan 4, 2025Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED 6 PICCS KINKED. ONE CATHETER WAS CONFIRMED TO BE KINKED VIA X-RAY; IT'S UNKNOWN HOW THE OTHER KINKS WERE DISCOVERED. PICCS WERE REMOVED, REPOSITIONED, REMOVED, AND/OR REPLACED. TWO PICCS WERE TREATED WITH TPA. PICC DWELL TIME RANGED FROM 0 TO 11 DAYS. THIS REPORT ADDRESSES ALL SIX DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075673 ↗
• MalfunctionJul 18, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT WIRE UNRAVELED WHILE PLACING IN A PATIENT. PATIENT NEEDED A NEW KIT AND AN XRAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772447 ↗
• MalfunctionMar 26, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE GREEN SECURE LOCK NEEDLE INSIDE THE TRIPLE LUMEN PICC KIT HAD THE GREEN SAFETY PART COME COMPLETELY OFF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979835 ↗
• MalfunctionDec 7, 2023

  INTERNAL READ OF EKG DID NOT COMMUNICATE WITH MACHINE TO VERIFY CORRECT PLACEMENT; THEREFORE, X-RAY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282889 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC NOT WORKING, PER FLOOR NURSE. PICC WAS REMOVED ON (B)(6). SMALL HOLE IN PICC NOTICED BY PICC RN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730575 ↗
• MalfunctionJun 20, 2023Unable to Obtain Readings; Defective Component; Unable to Obtain Readings; Defective Component

  IT WAS REPORTED THAT PICC APPEARS TO BE DROPPING INTO SVC. HEADING DOWNWARD. THEN, MAGNIFYING GLASS FLIPS UP TO TOP RIGHT CORNER OF SHERLOCK. TRIED TO RECALIBRATE MULTIPLE TIMES TO SEE WHETHER THAT WOULD FIX IT BUT CONTINUED TO FLIP UP AWAY FROM SVC. X-RAY CONFIRMS LOW SVC OF PICC TIP. ADDITIONAL INFORMATION RECEIVED 5/31/2023: "CUSTOMER REPORTS THEY HAVEN¿T HAD ANY NEW NURSES. CUSTOMER SUSPECTS ISSUE WITH THE PICC SENSOR; SOMETHING WITH THE TECHNOLOGY WIRE IN THE PICCS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167772 ↗
• MalfunctionMay 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, "A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2022 WAS FOUND TO BE KINKED ON (B)(6) 2022 IN THE UPPER 1/3 OF THE UPPER EXTREMITY. PICC DWELL TIME WAS 15 DAYS. PICC WAS PULLED BACK, WHICH RESOLVED THE KINK BUT THE TIP WAS TOO SHORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924401 ↗
• MalfunctionMay 12, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER, "A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BRACHIAL VEIN ON (B)(6) 2022 WAS FOUND TO BE KINKED ON (B)(6) 2022 IN THE UPPER 1/3 OF THE UPPER EXTREMITY. PICC DWELL TIME WAS 13 DAYS. PICC WAS PULLED BACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924400 ↗
• MalfunctionMay 11, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2023. ON (B)(6) 2023, THE CATHETER WAS TPA'D IN BOTH LUMENS BUT DIDN'T WORK. X-RAY SHOWED A KINK IN THE SUBCLAVIAN REGION ON (B)(6) 2023. PICC DWELL TIME WAS 17 DAYS. PICC WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916655 ↗
• MalfunctionMay 11, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2023 WAS FOUND TO BE KINKED ON (B)(6) 2023 IN THE AXILLARY REGION. PICC DWELL TIME WAS 13 DAY. PICC WAS EXCHANGED BY IR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916534 ↗
• MalfunctionMay 11, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE LEFT UPPER ARM BRACHIAL VEIN ON (B)(6) 2022 WAS FOUND TO BE KINKED ON (B)(6) 2022 NEAR THE INSERTION SITE. PICC DWELL TIME WAS 10 DAYS. TPA WAS INSTILLED IN 2 LUMENS ON (B)(6) 2022 WITHOUT GOOD RESULT SO AN X-RAY WAS REQUESTED TO ASSESS FOR A KINK. THE KINK RESULTED IN A DELAY IN INFUSING ALBUMIN. PICC WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915910 ↗
• MalfunctionMay 11, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2023. CATHETER WAS TPA'D IN ONE LUMEN ON (B)(6) AND ONE ON (B)(6) . CATHETER CONTINUED TO HAVE PERSISTENT ISSUES WITH FUNCTIONALITY. CHEST X-RAY WAS REQUESTED TO ASSESS FOR KINK. KINK NEAR THE INSERTION SITE CONFIRMED ON (B)(6). PICC WAS PULLED BACK 2CM ON (B)(6) AND KINK RESOLVED. HOWEVER, PICC TIP IS NOW IN THE UPPER SVC AND "MAY NEED REPLACEMENT". PICC DWELL TIME WAS 17 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915588 ↗
• MalfunctionMay 11, 2023Material Deformation; Material Deformation

  CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2023 WAS FOUND TO BE KINKED ON (B)(6) 2023 NEAR THE INSERTION SITE. ON (B)(6) , TWO LUMENS WERE SLUGGISH TO FLUSH WITH NO BLOOD RETURN SO TPA WAS INSTILLED. ON (B)(6), LUMENS WERE AGAIN SLUGGISH TO FLUSH WITHOUT BLOOD RETURN SO AN X-RAY OF THE RIGHT UPPER EXTREMITY WAS TAKEN AND SHOWED A CATHETER KINK NEAR THE INSERTION SITE. PICC DWELL TIME WAS 41 DAYS. CUSTOMER STATES THIS WAS USER ERROR. DRESSING WAS CHANGED AND HUB REPOSITIONED TO HAVE MORE GRADUAL TURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914921 ↗