PowerPICC Provena S1274108D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741154744), received between Jan 7, 2021 and Feb 25, 2025 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (21 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY PIECE OF THE ACCESS NEEDLE BECOME UNATTACHED DURING SAFETY DEPLOYMENT. NO OTHER INFORMATION WAS PROVIDED AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458749 ↗
• MalfunctionDec 12, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT SAFETY DEVICE CAME OFF THE NEEDLE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921268 ↗
• InjuryDec 9, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THEY EXPERIENCED A FAILED SAFETY ACCESS CATHETER. THE RN WAS SENT TO THE ED DUE TO BEING STUCK WITH A DIRTY NEEDLE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20880152 ↗
• MalfunctionNov 14, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE GREEN SAFETY COVER SLIDES COMPLETELY OFF OF THE NEEDLE. NO HARM. NO NEEDLESTICK, THE CLINICIAN RECOGNIZED THE ISSUE IN TIME TO PREVENT HARM. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL 3 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691755 ↗
• MalfunctionAug 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, EXTREME DIFFICULTY ADVANCING INTRODUCER SHEATH FROM PICC KIT. UNABLE TO COMPLETELY ADVANCE INTRODUCER SHEATH INTO VESSEL ON BUNCHED UP UNDER SKIN. DIFFERENT LOT USED AND ABLE TO ADVANCE WITH SOME DIFFICULTY HOWEVER ABLE TO USE PRODUCT FROM DIFFERENT LOTS. HAD TO ABORT USING BD PRODUCT AND DROP AN ARROW INTRODUCER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956611 ↗
• MalfunctionAug 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, EXTREME DIFFICULTY ADVANCING INTRODUCER SHEATH FROM PICC KIT. UNABLE TO COMPLETELY ADVANCE INTRODUCER SHEATH INTO VESSEL ON BUNCHED UP UNDER SKIN. DIFFERENT LOT USED AND ABLE TO ADVANCE WITH SOME DIFFICULTY HOWEVER ABLE TO USE PRODUCT FROM DIFFERENT LOTS. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924746 ↗
• MalfunctionAug 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, EXTREME DIFFICULTY ADVANCING INTRODUCER SHEATH FROM PICC KIT. UNABLE TO COMPLETELY ADVANCE INTRODUCER SHEATH INTO VESSEL ON BUNCHED UP UNDER SKIN. DIFFERENT LOT USED AND ABLE TO ADVANCE WITH SOME DIFFICULTY HOWEVER ABLE TO USE PRODUCT FROM DIFFERENT LOTS. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924720 ↗
• MalfunctionJun 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED 3/24: 1.5 CM MIGRATED OUT & NOT CENTRALLY LOCATED; 3/25: CATHETER POSITIONALLY OCCLUDED CXR NEG FOR KINK; 4/29: CATHETER NOW WITH 8 CM EXTERNAL; 5/9: CATHETER 9 CM EXTERNAL; 5/26 CATHETER D/C'D WITH KINK AT 18 CM MARK. DUE TO NON-CENTRAL TIP POSITION AND MIGRATION OF LINE, LINE WITH INTERMITTENT OCCLUSION AND SLUGGISH BLOOD RETURN BUT DID COMPLETE THERAPY. INITIALLY SECURED WITH SECURLOCK, THEN STATLOCK. 11CM ABOVE ANTECUBITAL FOSSA 11CM, 4CM EXTERNAL. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639693 ↗
• InjuryNov 22, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT ¿ONE OF MY VASCULAR ACCESS NURSES WAS IN THE MIDDLE OF A PROCEDURE WHEN HE STUCK HIMSELF BY REACHING ONTO THE TRAY. HE HAD JUST REMOVED THE NEEDLE FROM THE CATHETER AND THE SAFETY DID NOT ENGAGE." 11/8/2023: IT WAS REPORTED THE PATIENT WAS ADMITTED WITH N/V. THE EVENT DIDN'T INVOLVE AN URGENT OR LIFE-THREATENING MEDICAL SITUATION OR DELAYS IN TREATMENT. NO ADVERSE EVENT OTHER THAN THE EMPLOYEE BEING STUCK WITH A DIRTY NEEDLE. THE TREATMENT WAS COMPLETED WITH LINE INSERTION AND THERE WAS NO CHANGE IN CARE. (B)(6) 2023: IT WAS REPORTED BY THE CUSTOMER "LABS WERE DRAWN, PATIENT DOES NOT HAVE ANY BLOOD-BORNE DISEASES THAT WE ARE AWARE OF. EVENT WAS REPORTED TO FACILITY EMPLOYEE HEALTH. LABS DRAWN ON THE CLINICIAN FOR BASELINE AND WE FOLLOWED OUR POST NEEDLE STICK POLICY."

  Patient problems: Needle Stick/Puncture

  MAUDE report 18193936 ↗
• MalfunctionAug 15, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE CUSTOMER PLACED A PICC IN THE ICU SATURDAY AND THE T EXTENSION THAT THE GUIDE WIRE GOES INTO THE PICC HAD LEAKED. THEY FOUND THIS AFTER THEY HAD PLACED THE PICC AND WAS NEARLY DONE WITH EVERYTHING, THEY WENT TO CHECK FOR BLOOD RETURN AND GOT AIR BUBBLES. AFTER THEY SAW THAT, THEY FOUND THE MEMBRANE WAS LOOSE IN THE CONNECTOR AND THEY WAS ABLE TO PLUG IT WITH MY THUMB AND FLUSH AND GET BLOOD RETURN WITHOUT DIFFICULTY. THE CUSTOMER DIDN'T SAVE THE T CONNECTOR BECAUSE IT HAD BLOOD ON IT FROM TRYING TO FLUSH AND GET BLOOD RETURN. RESPONSE RECEIVED (B)(6) 2023. PATIENT NEEDED PICC LINE FOR PRESSORS, PLANNED TO GET LEVOPHED, POTASSIUM AND MAGNESIUM REPLACEMENT, CEFEPIME, AND HYDROCORTISONE. CAUSE A COUPLE MINUTE DELAY DURING INSERTION OF PICC LINE, NO DELAY IN CARE TO PATIENT. UPON INSERTION OF PICC WHEN ASPIRATING FOR BLOOD NOTICED PINK TINGED SALINE AND AIR BUBBLES TRAVELING INTO SYRINGE, INITIALLY WAS ABLE TO FLUSH LINE WITHOUT COMPLICATION. WHEN ATTEMPTING TO CHECK PLACEMENT AFTER ACCEPTABLE 3CG READING IS WHEN I NOTICED JUST BUBBLES AND NO BLOOD RETURN AND WHEN I FLUSHED THE LINE IT STARTED TO LEAK FROM THE MEMBRANE THAT THE WIRE TRAVELS THROUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549178 ↗
• MalfunctionJun 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT, "A 4 FR PROVENA KINK THAT IS STILL IN THE PATIENT THAT WE ARE MANIPULATING EXTERNALLY AS SHE SHOULD FINISH THERAPY SOON." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121789 ↗
• InjuryMay 4, 2023Suction Problem; Material Deformation; Suction Problem; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT, "ON 4/7/23 THE LINE WAS OCCLUDED AND WOULD NOT FLUSH OR DRAW. WHEN PATIENT'S ARM WAS LIFTED, THE LINE WOULD FLUSH AND DRAW. X-RAY SHOWED KINK NEAR INSERTION SITE. LINE RETRACTED 1 CM AND CATHETER DREW AND FLUSHED WITH EASE. ON 4/10/23, PICC (SAME LINE AS BEFORE) OCCLUDED. PICC WAS RETRACTED 1 CM. RED LUMEN WITH BRISK BLOOD RETURN FLUSHES EASILY, PURPLE LUMEN FLUSHES WITH MILD RESISTANCE AND HAD NO BLOOD RETURN. PATIENT ALSO COMPLAINING OF PAIN IN LEFT SHOULDER. AXILLARY ARM CIRCUMFERENCE NOTED TO BE 3CM GREATER THAN ON DATE OF INSERTION. AN ULTRASOUND WAS TAKEN THE SAME DAY AND SHOWED L BRACHIAL VEIN THROMBUS - NO NOTED FLOW AROUND PICC IN LEFT CEPHALIC VEIN BUT PROXIMAL AND DISTAL PORTIONS OF LEFT CEPHALIC VEIN APPEAR PATENT. THE CATHETER WAS REMOVED AND REPLACED. PER CLINICIAN, THE EVENT DID NOT OCCUR DURING AN URGENT OR LIFE-THREATENING MEDICAL SITUATION AND DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY IN TREATMENT."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16868252 ↗
• MalfunctionMar 3, 2023Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE PICC HAS GREAT BLOOD RETURN AND FLUSH WHEN PATIENT'S ARM IS ABDUCTED AWAY FROM BODY. BOTH LUMENS OF PICC ARE NOT PATENT WHEN ARM IS BY THE PATIENT'S SIDE. THIS VAT RN CONSULTED WITH PICC RN, ON HOW TO TROUBLESHOOT POSITIONAL PICC. PICC RN RECOMMENDED PULLING PICC 0.5CM. THIS VAT RN PULLED PICC 0.5CM DURING DRESSING CHANGED. PICC HAS GOOD BLOOD RETURN AND FLUSH IN BOTH LUMENS. ADDITIONAL INFORMATION RECEIVED ON 5/25/2023: CATHETER WAS INSERTED 8CM ABOVE THE ANTECUBITAL FOSSA AND 3CM LEFT OUTSIDE THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483091 ↗
• MalfunctionMar 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED, VAT CALLED TO TROUBLESHOOT PICC JUST EXCHANGED THIS MORNING. UPON ASSESSMENT, PICC COMPLETELY OCCLUDED AND UNABLE TO FLUSH OR DRAW BLOOD. XRAY IMAGE OBTAINED SHOWING SIMILAR KINKING OF CATHETER WITH PREVIOUS LINE. ADDITIONAL INFORMATION RECEIVED ON 2/28/2023: CATHETER WAS SECURED WITH SECURACATH. PATIENT BEING TREATED FOR SMALL BOWEL OBSTRUCTION WITH A MEDICAL HISTORY OF JEJUNAL ATRESIA AND MALROTATION S/P EX-LAP, RESECTION OF JEJUNAL ATRESIA WITH JEJUNO-JEJUNOSTOMY, AND LADD'S PROCEDURE IN INFANCY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483090 ↗
• MalfunctionMar 3, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER THAT "NO KINK FOUND BUT CATHETER REPLACED R/T MULTIPLE FAILED DECLOT ATTEMPTS. (B)(6) 2023 VAT REQUESTED TO TROUBLESHOOT PT'S PICC D/T LACK OF BLOOD RETURN IN RED LUMEN, UNABLE TO GET TO FUNCTION APPROPRIATELY DESPITE SEVERAL TROUBLESHOOTING EFFORTS. SURGERY MESSAGED VIA CORUS'D TO RECOMMEND NEW PICC PLACEMENT AS PICC LINE HAS HAD >10 DOSES OF ALTEPLASE SINCE 1/1/2023. PICC REMOVED AND REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483089 ↗
• MalfunctionMar 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "UNABLE TO DECLOT LINE ON REMOVAL REALIZED IT WAS KINKED. LINE PLACED ON (B)(6) 2022. 1/5 DECLOT X 2 NOT SUCCESSFUL ON 1/7 DURING REMOVAL PICC RN COULD FEEL A KINK JUST RELEASE AS PICC WAS WITHDRAWN. XRAY IMAGE DOES NOT SHOW ARM OF PATIENT BUT OF NOTE TIP POSITIONING IS SHORT." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 2/28/2023: IT WAS REPORTED BY THE CUSTOMER "CATHETER WAS SECURED WITH SECURACATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479863 ↗
• MalfunctionMar 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED, LINE WAS REMOVED DUE TO IT BEING POSITIONAL AND MULTIPLE KINKS IN CATHETER. RECOMMEND REPLACEMENT OF PICC SINCE PICC IS EXTREMELY POSITIONAL WITH ARM MOVEMENTS AND TIP IS IN MID SVC WHICH IS NOT IDEAL LOCATION FOR CPN. POSITIONAL ON LINE REMOVAL NOTED MULTIPLE KINKS IN CATHETER. NO XRAY IMAGE OF ARM OBTAINED. ADDITIONAL INFORMATION RECEIVED ON 5/25: CATHETER WAS INSERTED 9CM ABOVE THE ANTECUBITAL FOSSA WITH 4CM LEFT EXTERNAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478856 ↗
• MalfunctionMar 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "R BRACHIAL ATTEMPTED 10 CM ABOVE ANTECUBITAL FOSSA; LINE SUCCESSFULLY PLACED AND CONFIRMED WITH ECG, HOWEVER UPON PLACING DRESSING RED LUMEN VERY DIFFICULT TO FLUSH. DRESSING REMOVED AND ASSESSED, WITH NO VISIBLE KINKS; CXR TAKEN TO ASSESS TIP LOCATION, AND KINK NOTED IN ARM. ATTEMPTED TO RETRACT LINE TO RELEASE KINK BUT UNSUCCESSFUL. NEW PICC LINE PLACED." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 5/25/2023: CATHETER INSERTED 8CM ABOVE THE ANTECUBITAL FOSSA WITH 8CM EXTERNAL TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478579 ↗
• MalfunctionMar 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "LINE PLACED (B)(6) 2022. 1/5 DECLOT X 2 NOT SUCCESSFUL ON 1/7 DURING REMOVAL PICC RN COULD FEEL A KINK JUST RELEASE AS PICC WAS WITHDRAWN. XRAY IMAGE DOES NOT SHOW ARM OF PATIENT BUT OF NOTE TIP POSITIONING IS SHORT." IT WAS STATED DEVICE WAS SECURED WITH CATHETER WAS SECURED WITH SECURACATH. ADDITIONAL INFORMATION RECEIVED 5/25: CATHETER WAS PLACED 12CM ABOVE THE ANTECUBITAL FOSSA WITH 4CM LEFT EXTERNAL TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475616 ↗
• MalfunctionMar 2, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER, "SEVEN DAYS AFTER INSERTION LINE KINKED. ON (B)(6) 2023 DISCUSSED WITH UNIT RN PICC LINE NOW DRAWING BLOOD AND VERY HARD TO FLUSH. PICC WAS DECLOTTED ON (B)(6) AND (B)(6). PATIENT AND MOM STATE LINE IS VERY POSITIONAL AND OCCLUDING OFTEN. RECOMMEND CHEST XRAY WITH LEFT ARM INCLUDED TO CHECK FOR KINKS IN LINE. PICC WAS REWIRED." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/28/2023: IT WAS REPORTED BY THE CUSTOMER "CATHETER WAS SECURED WITH SECURACATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475589 ↗
• MalfunctionMar 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 11/30 PATIENT PULLED OUT PICC. NO NEW PICC WAS INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461549 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "ON DAY OF INSERTION PICC WITHOUT BLOOD RETURN AND DIFFICULTY FLUSHING. LINE PULLED BACK (TIP IN ATRIUM) BUT LINE CONTINUED TO HAVE ISSUES. LINE DECLOTTED ABOUT EVERY 2 DAYS UNTIL (B)(6) 2023 WHEN LINE REWIRED BY IR (PT COULD NOT TOLERATE BEDSIDE PROCEDURE). 1/31 REFERRED TO ONC PICC TEAM FOR EVALUATION OF EXCHANGED IR PICC. LINE FOUND KINKED UNDER STATSEAL RING PULLED BACK AND REDRESSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461538 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "(B)(6) 2023 CALLED TO ASSESS PATIENT LUA DL PICC, DUE TO OCCLUSION AND POSITIONAL SINCE LAST NIGHT, SEEN BY VAT RN, NOTED WITH BRISK BLOOD RETURN ON BOTH LUMEN, DRESSING IS INTACT NO VISIBLE KINK, CPN AND IV FLUIDS FLOWING VERY GOOD WHEN ARM IS ABDUCT AND ADDUCT , BUT WHEN ASK PATIENT TO RAISED HIS ARM ABOVE HIS HEAD , IV PUMP STARTED TO BEEP AND OCCLUSION DETECTED, POSSIBLE CATHETER ISSUE AS SEEN IN CXR ,ABOUT 7-8 CM ABOVE THE SITE NOTED INTRA LUMEN (POSSIBLE KINK/LINE FRACTURE)." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461257 ↗
• MalfunctionMar 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "(B)(6) 2022 LINE FLUSHED WELL AND HAD BLOOD RETURN WHEN HOLDING LIGHT TRACTION ON EXTERNAL PORTION OF LINE BUT OCCLUDED WHEN TRACTION REMOVED. SECURACATH REMOVED BUT PROBLEM PERSISTED WITH STATLOCK IN PLACE. AFTER X-RAY CONFIRMED KINK, LINE RETRACTED 3-4 CM AND THEN BRISK BLOOD RETURN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461007 ↗
• MalfunctionFeb 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, WE HAD A PROVENA PICC LEAKING AT THE PURPLE HUB A COUPLE DAYS WITHIN PLACEMENT. THE PICC WAS REWIRED TO A 5 FR DOUBLE AND NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371858 ↗