PowerPICC Provena S1395108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00801741112751), received between Nov 16, 2017 and Dec 10, 2025 — classified as 8 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16, 2026.

Recalls naming this device

1. May 21, 2026Open, 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED 5FR TL SECURLOC NEEDLE DID NOT SAFETY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768250 ↗
• MalfunctionDec 5, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE SAFETY MECHANISM DID NOT ACTIVATE DURING PICC INSERTION AND DETACHED COMPLETELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727996 ↗
• MalfunctionNov 18, 2025Activation Problem; Activation Problem

  IT WAS REPORTED SECUR-LOC INTRODUCER NEEDLES DID NOT SAFETY DURING PICC INSERTION. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584785 ↗
• MalfunctionNov 5, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHILE ACCESSING PATIENT FOR PICC LINE, GOT INTO VEIN WITH GREEN ACCESS NEEDLE, THREAD GUIDEWIRE AND REMOVED ACCESS NEEDLE OVER THE WIRE, ATTEMPTED TO SAFETY GREEN ACCESS NEEDLE AND THE GREEN SAFETY FLEW OFF LEAVING US UNABLE TO SAFETY THE NEEDLE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476033 ↗
• MalfunctionOct 22, 2025Activation Problem; Activation Problem

  IT WAS REPORTED "MY STAFF WAS JUST PLACING A PICC LINE AND THE STEEL NEEDLE IN THE KIT WITH THE BIG GREEN SHARPS SAFETY DEVICE CAME APART WHEN THEY REMOVED IT FROM THE PATIENT. THE BIG GREEN SAFETY SLID RIGHT OFF EXPOSING THE SHARP END." PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357693 ↗
• MalfunctionAug 7, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT SAFETY MECHANISM ON NEEDLE DID NOT SAFETY PROPERLY. ADDITIONAL INFORMATION RECEIVED: A PICC WAS BEING PLACED AND WHEN IT WAS REMOVED FROM PATIENT AND WE ATTEMPTED TO SAFETY IT THE GREEN SAFETY FLEW OFF AND LUCKILY THERE WAS NOT A NEEDLE STICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737750 ↗
• MalfunctionAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS ENQUIRED BY CUSTOMER THAT THEY NEED TO KNOW THE INTERNAL DIAMETER OF THE POWERPICC TO KNOW WHAT GUIDEWIRE TO USE TO ADJUST THE PATIENT'S PICC.

  Patient problems: Insufficient Information

  MAUDE report 22719343 ↗
• MalfunctionJun 24, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY CATCH ON ONE OF OUR NEEDLES CAME OFF DURING THE PICC WHEN WE TRIED TO SECURE IT. NO HARM TO THE PATIENT OR CLINICIAN. NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323829 ↗
• MalfunctionSep 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THE CUSTOMER HAD A PICC THAT THEY ARE HAVING ISSUES WITH GETTING AIR IN THE LINES THRU THE RUBBER PIECE WITH PULLING BACK AND FLUSHING LINE DURING PLACEMENT. ADD INFO RECEIVED ON 07-SEP-2023: THE EVENT DIRECTLY INVOLVED USER. NO URGENT/LIFE THREATENING MEDICAL SITUATION. NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO INTERRUPTION OF THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT. NO ADDITIONAL, UNPLANNED MEDICAL OR SURGICAL INTERVENTION REQUIRED TO AVOID PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798957 ↗
• MalfunctionSep 18, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT CUSTOMER HAD ISSUES WITH GETTING AIR IN THE LINE THRU THE RUBBER PIECE WITH PULLING BACK AND FLUSHING LINE DURING PLACEMENT. NO OTHER INFORMATION WAS PROVIDED. ADD INFO RECEIVED ON (B)(6) 2023. NO URGENT/LIFE THREATENING MEDICAL SITUATION. NO PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO INTERRUPTION OF THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT. NO ADDITIONAL, UNPLANNED MEDICAL OR SURGICAL INTERVENTION REQUIRED TO AVOID PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769641 ↗
• MalfunctionAug 9, 2023Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT INTRODUCER HAS MALFORMATION ON THE GRAY PART AND DOES NOT ALLOW WIRE TO THREAD. ADD INFO RECEIVED ON 21-JUL-2023. DIRECTLY INVOLVE PATIENT, THE INTRODUCER WOULDN¿T THREAD INTO PATIENT BECAUSE OF THE BURR ON THE END OF IT. THE ATTEMPTS MADE TO THREAD INTRODUCER FAILED AND TRAUMA IN TRYING TO USE IT AS WE NORMALLY WOULD MAY HAVE CAUSED SOME DAMAGE AND I¿M SURE INCREASED THE RISK OF DVT. WE WERE ABLE TO DROP A INTRODUCER KIT ONTO STERILE FIELD AND USE A NEW INTRODUCER WHICH THREAD EASILY INTO PATIENT AND ALLOWED US TO FINISH HIS PICC LINE INSERTION AT BEDSIDE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17492759 ↗
• MalfunctionJun 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, ACCOUNT STATES THEY HAVE PLACED FOUR 5FR DL PICCS THAT <12 HOURS OF BEING PLACED, NONE OF THE LUMENS WILL DRAW AND CAN'T BE FLUSHED. STATES THERE HAVE BEEN DIFFERENT PLACERS, AND EACH PLACERS HAS STATED ZERO ISSUES WITH PLACEMENTS. STATES AFTER PLACEMENT EACH OF THE LUMENS DREW BLOOD AND HAD NO ISSUES. TROUBLE SHOOTING WAS PERFORMED: CATHFLO WITH NO IMPROVEMENT. AND STILL WAS UNABLE TO GET BLOOD RETURN AND HAD DIFFICULTY FLUSHED. AN XRAY WAS PERFORMED ON ALL FOUR PICCS AND THE XRAY SHOWED CORRECT PLACED OF THE LINE. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240784 ↗
• MalfunctionJun 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, ACCOUNT STATES THEY HAVE PLACED FOUR 5FR DL PICCS THAT <12 HOURS OF BEING PLACED, NONE OF THE LUMENS WILL DRAW AND CAN'T BE FLUSHED. STATES THERE HAVE BEEN DIFFERENT PLACERS, AND EACH PLACERS HAS STATED ZERO ISSUES WITH PLACEMENTS. STATES AFTER PLACEMENT EACH OF THE LUMENS DREW BLOOD AND HAD NO ISSUES. TROUBLE SHOOTING WAS PERFORMED: CATHFLO WITH NO IMPROVEMENT. AND STILL WAS UNABLE TO GET BLOOD RETURN AND HAD DIFFICULTY FLUSHED. AN XRAY WAS PERFORMED ON ALL FOUR PICCS AND THE XRAY SHOWED CORRECT PLACED OF THE LINE. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240776 ↗
• MalfunctionJun 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, ACCOUNT STATES THEY HAVE PLACED FOUR 5FR DL PICCS THAT <12 HOURS OF BEING PLACED, NONE OF THE LUMENS WILL DRAW AND CAN'T BE FLUSHED. STATES THERE HAVE BEEN DIFFERENT PLACERS, AND EACH PLACERS HAS STATED ZERO ISSUES WITH PLACEMENTS. STATES AFTER PLACEMENT EACH OF THE LUMENS DREW BLOOD AND HAD NO ISSUES. TROUBLE SHOOTING WAS PERFORMED: CATHFLO WITH NO IMPROVEMENT. AND STILL WAS UNABLE TO GET BLOOD RETURN AND HAD DIFFICULTY FLUSHED. AN XRAY WAS PERFORMED ON ALL FOUR PICCS AND THE XRAY SHOWED CORRECT PLACED OF THE LINE. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240772 ↗
• MalfunctionJun 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, ACCOUNT STATES THEY HAVE PLACED FOUR 5FR DL PICCS THAT <12 HOURS OF BEING PLACED, NONE OF THE LUMENS WILL DRAW AND CAN'T BE FLUSHED. STATES THERE HAVE BEEN DIFFERENT PLACERS, AND EACH PLACERS HAS STATED ZERO ISSUES WITH PLACEMENTS. STATES AFTER PLACEMENT EACH OF THE LUMENS DREW BLOOD AND HAD NO ISSUES. TROUBLE SHOOTING WAS PERFORMED: CATHFLO WITH NO IMPROVEMENT. AND STILL WAS UNABLE TO GET BLOOD RETURN AND HAD DIFFICULTY FLUSHED. AN XRAY WAS PERFORMED ON ALL FOUR PICCS AND THE XRAY SHOWED CORRECT PLACED OF THE LINE. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240763 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PROVIDER THAT THEY HAD A PATIENT WITH A POWERPICC PROVENA THAT WAS PLACED A FEW WEEKS AGO. WHEN REMOVING THE PICC FROM THE PATIENT, THE PIC WAS STUCK AND HAD ADHERED TO THE VESSEL WALL. PROVIDER STATES THE FIBRIN HAD BUILT UP AROUND THE CATHETER CAUSING IT TO GET STUCK TO THE VEIN WALL. INFORMED PROVIDER THE PICC CATHETER ADHERING TO THE VESSEL WALL IS UNCOMMON. THERE ARE FEW REPORTS OF VAD ADHERING TO THE VESSEL WALLS, I AM UNSURE OF ANY OCCURRENCE WITH THE POWERPICC PROVENA SPECIFICALLY. WE DO NOT HAVE SPECIFIC RECOMMENDATIONS FOR HOW TO REMOVE A PICC WHEN STUCK OR ADHERED TO THE VESSEL WALL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17204025 ↗
• MalfunctionMay 7, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS "ON SATURDAY (B)(6) 2022 NURSE AND I WERE PLACING A PICC LINE. PICC LINE INSERTION HAD NO COMPLICATION OR RESISTANCE, AND IT WAS A QUICK AND SMOOTH PROCEDURE. AFTER EVERY PICC LINE INSERTION WE ALWAYS DO A DOUBLE VERIFICATION TO MAKE SURE WE HAVE ALL THE MATERIALS FROM THE KIT AND THAT ALL WIRES ARE INTACT. HOWEVER, THE STYLET WIRE (WHICH IS THE WIRE THAT IS INSIDE THE PICC LINE CATHETER) WAS BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316218 ↗
• MalfunctionMar 24, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "LAST WEDNESDAY I WAS PLACING A PICC LINE IN CTU, AND AFTER THE PICC LINE WAS PLACED WE CHECKED THE STYLET WIRE, AND IT WAS BENT IN A 90 DEGREE ANGLE. THERE WAS NO RESISTANT AND THE CATHETER WENT DOWN SMOOTHLY. THE WIRE WAS NOT COILED OR BENT IN ANY WAY, JUST THE TIP WAS BENT WHEN WE CHECKED IT AFTER PLACING THE PICC LINE. BARELY TOUCHED THE TIP AFTERWARDS TO CHECK IT, AND IT BROKE OFF." WERE ALL THE MISSING/BROKEN PIECES RETRIEVED AND ACCOUNTED FOR? YES. WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895529 ↗
• MalfunctionMar 8, 2022Break

  BARD POWERPICC PROVENA STYLET BROKE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13710932 ↗
• MalfunctionFeb 25, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "WE HAD AN ISSUE WITH INTRODUCER ON THE TRIPLE LUMEN PROVENA PICC LINE, 5 FR. THE PICC RN WAS TRYING TO THREAD THE INTRODUCER IN THE PATIENT AND COULDN¿T, NICKED HIM WITH THE SCALPEL AND STILL COULDN¿T, FINALLY REALIZING THERE WAS A SMALL BURR ON THE END OF THE GRAY PART OF THE INTRODUCER. ANOTHER ONE HAD TO BE DROPPED TO HER ONTO HER STERILE FIELD. THE FIRST INTRODUCER FELT MORE FLIMSY TO THE INSERTER. THIS REPEATED PUSHING TRYING TO POP THE INTRODUCER THROUGH THE SKIN PUTS THIS COVID POSITIVE PATIENT AT HIGHER RISK FOR DVT WITH THAT MANIPULATION AND ALSO HAVING TO NICK HIS SKIN PUTTING HIM AT HIGHER RISK FOR INFECTION. SEVERAL SKIN NICKS HAD TO BE MADE UNTIL IT WAS REALIZED THAT THERE WAS A BURR ON THE END OF THE INTRODUCER. PATIENT IS 6¿4¿, HE IS HERE AND VENTED FOR COVID PNA. R IJ IN PLACE AS WELL AND WAS REMOVED ONCE THE PICC LINE WAS PLACED." WAS THERE ANY PATIENT HARM REPORTED? NO, BUT TRAUMA TO VEIN AND TISSUE AS ATTEMPTS MADE TO THREAD INTRODUCER BEFORE THE SMALL BURR ON THE END WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600779 ↗
• MalfunctionFeb 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT BURRS WERE NOTED ON TRIPLE LUMEN PROVENA PICC INTRODUCER RESULTING IN SKIN NICKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546045 ↗
• MalfunctionJan 11, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "WHEN PLACING A TL PICC, NURSE HAD DIFFICULTY PICKING UP THE ECG READING. SHE FLUSHED THE PICC AND NOTICED RESISTANCE WHILE FLUSHING. SHE PULLED THE PICC AND EXAMINED THREE FRACTURES IN THE STYLET." (B)(6) 2021 ADDITIONAL INFORMATION RECEIVED "THE DESCRIPTION OF THE INCIDENT IS NOT QUITE ACCURATE, THE 5 FR TRIPLE LUMEN POWER PICC CATHETER WAS TRIMMED TO A LENGTH OF 44CM. I HAD A HARD TIME GETTING THE CATHETER TO ADVANCE, AND WHEN I FLUSHED, THE WAS NO RESISTANCE (FELT ODD LINE WHEN THE EXTENSION TUBE OR NEEDLELESS CONNECTOR IS NOT CONNECTED) AT THAT POINT A HOLE IN THE CATHETER WAS SUSPECTED. I DECIDED TO DO AN EXCHANGE. WHILE PREPPING TO DO AN EXCHANGE, THE STYLET WAS REMOVED, AND I NOTICED A COIL AT THE TIP, AND NOTICED THAT THE TIP WAS NOT THE NORMAL LENGTH. OF NOTE, I TOUCHED THE COIL OF THE WIRE AND IT 1CM BROKE OFF. IT WAS THEN THAT A PORTION OF THE FRAGMENT WAS FOUND TO BE IN THE EXTENSION TUBING OF THE LUMEN. THE PROCEDURE WAS ABORTED, A REQUEST WAS MADE FOR A STAT CXR TO ASSESS FOR RETAINED WIRE. THERE WAS NO WIRE FOUND IN PATIENT. THE STYLET WAS INSPECTED BY 3 PICC RNS AND WAS MEASURED TO BE EQUAL TO THOSE THAT ARE NORMALLY INTACT." WAS THERE ANY PATIENT H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13232355 ↗
• InjurySep 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC LINE AND DIALYSIS CATHETER INSERTIONS PLACED IN PATIENT ON AUGUST 6TH. CHEST X-RAY DONE AFTER PLACEMENT OF BOTH CATHETERS- THE FILM SHOWED A FRAGMENTED PIECE OF WIRE BUT WAS NOT DISCOVERED OR NOTED BY STAFF UNTIL PATIENT HAD CT YESTERDAY AND IT WAS EVIDENTLY NOTED A RETAINED WIRE IN THE PATIENTS LUNG. IT WAS REMOVED BY IR YESTERDAY AND SENT TO PATHOLOGY. RISK MANAGEMENT NOTIFIED INTERNALLY. VASCULAR ACCESS NURSE DID NOTE THAT INSERTION OF PICC LINE WAS VERY DIFFICULT TO PLACE DUE TO THE PATIENTS MEDICAL HISTORY AND ANATOMY."

  Patient problems: Foreign Body In Patient

  MAUDE report 12517141 ↗
• MalfunctionAug 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE WERE PLACING A TRIPLE LUMEN PICC LAST WEEK AND NOTICED LEAKING AROUND THE HUB/CATHETER RIGHT AFTER INSERTING THE PICC INTO THE PATIENT. WE HAVE THE SAMPLE THAT WE CAN SEND IN. THE LOT NUMBER IS REFP4380." ADDITIONAL INFO RCVD 07/20/2021 "RN PLACING LINE AND NOTED SALINE BUBBLES AT THE DISTAL HUB TIP WHILE ATTEMPTING TO FLUSH WHILE INSERTING LINE. LEAKING NOTED AND PICC REMOVED AND NEW LINE PLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278535 ↗
• MalfunctionJul 8, 2021Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent

  IT WAS REPORTED VIA PHONE CALL "THE GUIDEWIRE APPEARS TO BE BENT OR BROKEN, THIS OCCURRED DURING PLACEMENT. PATIENT HAS SINCE PASSED AWAY, UNRELATED TO THE DEVICE MALFUNCTION. PATIENT HAS SINCE PASSED AWAY, UNRELATED TO THE DEVICE MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136922 ↗