PowerPICC Provena S1173108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741130342), received between Nov 10, 2017 and Nov 10, 2023 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Defective Component; Defective Component

  IIT WAS REPORTED BY THE CUSTOMER THAT WHILE PLACING TRIPLE LUMEN PICC AND FLUSH SHOT OUT OF YELLOW RUBBER STOPPER AND WHEN TRIED TO ASPIRATE-GOT AIR BUBBLES FROM TOO LARGE OF HOLE IN YELLOW STOPPER. HAD TO HOLD FINGER OVER GUIDEWIRE HOLE TO USE. ADDITIONAL INFORMATION RECEIVED ON 23-OCT-2023: IT WAS REPORTED BY THE CUSTOMER "DURING THE PICC INSERTION, I ATTEMPTED TO FLUSH, AND THE SALINE SPRAYED OUT OF THE CLEAR SILICONE PIECE THAT THE STYLET GOES THROUGH. WHEN I ATTEMPTED TO ASPIRATE BLOOD, I PULLED BACK AIR. I HAD TO HOLD MY THUMB FIRMLY OVER THE END IN ORDER TO FLUSH AND ASSESS FOR BLOOD RETURN. NO PATIENT HARM. THE OUTCOME WAS SUCCESSFUL SINGLE LUMEN PICC PLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113357 ↗
• MalfunctionNov 1, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE PLACING TRIPLE LUMEN PICC AND FLUSH SHOT OUT OF YELLOW RUBBER STOPPER AND WHEN TRIED TO ASPIRATE-GOT AIR BUBBLES FROM TOO LARGE OF HOLE IN YELLOW STOPPER. HAD TO HOLD FINGER OVER GUIDEWIRE HOLE TO USE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: IT WAS REPORTED THAT "DURING THE PICC INSERTION, I ATTEMPTED TO FLUSH, AND THE SALINE SPRAYED OUT OF THE CLEAR SILICONE PIECE THAT THE STYLET GOES THROUGH. WHEN I ATTEMPTED TO ASPIRATE BLOOD, I PULLED BACK AIR. I HAD TO HOLD MY THUMB FIRMLY OVER THE END IN ORDER TO FLUSH AND ASSESS FOR BLOOD RETURN. NO PATIENT HARM. THE OUTCOME WAS SUCCESSFUL SINGLE LUMEN PICC PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049723 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17844313 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE SEVENTH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17844312 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE SIXTH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17844311 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17844310 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17844228 ↗
• MalfunctionSep 29, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT IN THE KITS, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE PICC CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. ADDITIONAL INFORMATION RECEIVED 21 AUGUST 2023: THE EVENT DID DIRECTLY INVOLVE A PATIENT AND A USER. EVENT DID NOT EFFECT THE PATIENT. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION. NO HARM CAME TO THE PATIENT, AND THEY DID NOT REQUIRE ANY TREATMENT AS A RESULT OF THE EVENT. THE EVENT DID NOT LEAD TO ANY DELAY IN PATIENT CARE. THE PROBLEM WAS THAT THE PICC COULD NOT BE FLUSHED WITH THE GUIDEWIRE PRESENT ONCE BLOOD RETURN HAD BEEN CHECKED, SINCE WITHDRAWING BLOOD ALSO DREW AIR INTO THE EXTENSION TUBING. ONCE AIR WAS IN THE EXTENSION TUBING, THE LINE COULD NOT BE FLUSHED UNTIL THE WIRE WAS REMOVED. IF THE LINE HAD BEEN FLUSHED WITH AIR, THE PATIENT WOULD HAVE SUSTAINED AN AIR EMBOLISM. WITHOUT BEING ABLE TO FLUSH THE LINE PRIOR TO WIRE REMOVAL, THE LINE COULD HAVE CLOTTED OFF DURING PLACEMENT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844102 ↗
• MalfunctionSep 29, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT IN THE KITS, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE PICC CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. ADDITIONAL INFORMATION RECEIVED 21 AUGUST 2023: THE EVENT DID DIRECTLY INVOLVE A PATIENT AND A USER. EVENT DID NOT EFFECT THE PATIENT. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION. NO HARM CAME TO THE PATIENT, AND THEY DID NOT REQUIRE ANY TREATMENT AS A RESULT OF THE EVENT. THE EVENT DID NOT LEAD TO ANY DELAY IN PATIENT CARE. THE PROBLEM WAS THAT THE PICC COULD NOT BE FLUSHED WITH THE GUIDEWIRE PRESENT ONCE BLOOD RETURN HAD BEEN CHECKED, SINCE WITHDRAWING BLOOD ALSO DREW AIR INTO THE EXTENSION TUBING. ONCE AIR WAS IN THE EXTENSION TUBING, THE LINE COULD NOT BE FLUSHED UNTIL THE WIRE WAS REMOVED. IF THE LINE HAD BEEN FLUSHED WITH AIR, THE PATIENT WOULD HAVE SUSTAINED AN AIR EMBOLISM. WITHOUT BEING ABLE TO FLUSH THE LINE PRIOR TO WIRE REMOVAL, THE LINE COULD HAVE CLOTTED OFF DURING PLACEMENT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843740 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17843637 ↗
• MalfunctionSep 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HAVING SOME ISSUES WITH SINGLE LUMEN PICC KITS. THE PROBLEM IS WITH THE STOPPER PART THAT THE STYLET WIRE GOES THROUGH. LEAKING WHERE THE WIRE COMES OUT OF THE STOPPER AND AIR COMING BACK INTO THE SYRINGE WHEN ASPIRATING. THE MATERIALS IN THIS PART OF THE PICC HAVE CHANGED IN THE LAST COUPLE MONTHS. ADDITIONAL INFORMATION RECEIVED 08/25/2023. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. NO PATIENT HARM OCCURRENT. STAFF NOTED ISSUE AND WORKED TO AVOID INJECTION OF AIR OR OCCLUSION OF BLOOD DUE TO UNEXPECTED BACK UP WITHIN THE PICC CATHETER. THE EVENT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725639 ↗
• MalfunctionSep 8, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT IN SOME OF THE KITS RECENTLY, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE MIDLINE CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. IT WAS REPORTED THIS OCCURRED WITH SEVEN DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 17712239 ↗
• MalfunctionSep 6, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HAVING SOME ISSUES WITH SINGLE LUMEN PICC KITS WITH THE REHQ1754 LOT NUMBER. THE PROBLEM IS WITH THE STOPPER PART THAT THE STYLET WIRE GOES THROUGH. LEAKING WHERE THE WIRE COMES OUT OF THE STOPPER AND AIR COMING BACK INTO THE SYRINGE WHEN ASPIRATING. ADDITIONAL INFORMATION 8/25: THIS EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION, AND NO PATIENT HARM OCCURRENT. STAFF NOTED ISSUE AND WORKED TO AVOID INJECTION OF AIR OR OCCLUSION OF BLOOD DUE TO UNEXPECTED BACK UP WITHIN THE PICC CATHETER. NO REPORTED NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695961 ↗
• MalfunctionAug 29, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT IN THE KITS, THE RUBBER STOPPER HOLDING THE WIRE IN PLACE INSIDE THE CATHETER DOES NOT FULLY SEAL. DURING INSERTION, WHEN THE PICC CONTAINING THE WIRE IS CHECKED FOR BLOOD RETURN, AIR ENTERS THE CLEAR PLASTIC EXTENSION PIECE, PUTTING THE PATIENT AT RISK FOR AIR EMBOLISM, AND IF FLUSHED THEN FLUID LEAKS OUT WHERE THE WIRE GOES IN. ADDITIONAL INFORMATION RECEIVED 21 AUGUST 2023: THE EVENT DID DIRECTLY INVOLVE A PATIENT AND A USER. EVENT DID NOT EFFECT THE PATIENT. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION. NO HARM CAME TO THE PATIENT, AND THEY DID NOT REQUIRE ANY TREATMENT AS A RESULT OF THE EVENT. THE EVENT DID NOT LEAD TO ANY DELAY IN PATIENT CARE. THE PROBLEM WAS THAT THE PICC COULD NOT BE FLUSHED WITH THE GUIDEWIRE PRESENT ONCE BLOOD RETURN HAD BEEN CHECKED, SINCE WITHDRAWING BLOOD ALSO DREW AIR INTO THE EXTENSION TUBING. ONCE AIR WAS IN THE EXTENSION TUBING, THE LINE COULD NOT BE FLUSHED UNTIL THE WIRE WAS REMOVED. IF THE LINE HAD BEEN FLUSHED WITH AIR, THE PATIENT WOULD HAVE SUSTAINED AN AIR EMBOLISM. WITHOUT BEING ABLE TO FLUSH THE LINE PRIOR TO WIRE REMOVAL, THE LINE COULD HAVE CLOTTED OFF DURING PLACEMENT O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642867 ↗
• MalfunctionApr 14, 2023Material Deformation; Material Deformation

  IT WAS REPORTED, 3FR PROVENA PICC, THE MICROINTRODUCER BUCKLED IN ON ITSELF. "I MADE A SMALL NICK, THEN TOOK THE WHITE INTERNAL PIECE OF THE DIALATOR TO PRE-DIALATE BECAUSE I ALWAYS HAVE ISSUES WITH THE 3 FR ONES. I PUT THE TWO PIECES BACK TOGETHER TO DIALATE AGAIN AND IT BUCKLED BACK ON ITSELF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748221 ↗
• MalfunctionDec 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "PER VAT TEAM MEMBER "TWO 3FS PICC INTRODUCERS ARE LONG AND FLIMSY. ONE HAS A WHITE RIDGE AND THE INSERTER WAS NOT ABLE TO GET IT THROUGH THE PATIENT'S SKIN. THE SECOND ONE GOT A BURR ON THE END TRYING TO INSERT IN THE PATIENT'S SKIN AND A FEW NOTCHES IN THE OUTSIDE CHANNEL." THIS REPORT ADDRESSES THE INSERTER WITH THE WHITE RIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039746 ↗
• MalfunctionDec 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "PER VAT TEAM MEMBER "TWO 3FS PICC INTRODUCERS ARE LONG AND FLIMSY. ONE HAS A WHITE RIDGE AND THE INSERTER WAS NOT ABLE TO GET IT THROUGH THE PATIENT'S SKIN. THE SECOND ONE GOT A BURR ON THE END TRYING TO INSERT IN THE PATIENT'S SKIN AND A FEW NOTCHES IN THE OUTSIDE CHANNEL." THIS REPORT ADDRESSES THE INSERTER WITH THE BURR AT THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039723 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH REPORT "A 3 FR PROVENA POWERPICC BEGAN LEAKING FROM HUB WHERE CLAVE ATTACHES. LINE HAD TO BE REMOVED AND A #4 FR POWERPICC INSERTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117966 ↗
• MalfunctionApr 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH " 3FR "SINGLE" POWERPICC INSERTED ON "(B)(6) 2022" BEGAN LEAKING AT HUB WHERE "CLAVE" IS NEEDED TO BE REMOVED AND ANOTHER #4FR POWERPICC INSERTED PICC STARTED LEAKING FROM HUB WHERE "CLAVE" CONNECTED #3 FR PROVENA POWERPICC BEGAN LEAKING FROM HUB WHERE CLAVES ATTACHES LINE HAD TO BE REMOVED AND A #4FR POWERPICC INSERTED." THIS REPORT ADDRESSES THE 3FR PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054028 ↗
• MalfunctionApr 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DILATOR BUCKLED WHEN INTRODUCED. WHEN NURSE WENT TO INTRODUCE, THE END OF THE DILATOR FLIPPED UP AND WAS UNABLE TO ADVANCE THE DILATOR FURTHER. A NEW KIT WAS OPENED AND THE NEXT DILATOR WENT SMOOTH. THERE WAS NO DAMAGE TO THE PATIENT BUT IT DID CAUSE DELAYS IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046128 ↗
• MalfunctionMar 21, 2022Output Problem

  WHEN ATTEMPTING TO PLACED DILATOR AT INSERTION SITE, THE TIP FLOWERED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13847417 ↗
• MalfunctionApr 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED SHERLOCK STYLET BROKE AFTER TAKING IT OUT OF THE PICC DURING THE PROCEDURE TO TROUBLESHOOT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: PLACEMENT INFO: PICC INSERTION BUT CATHETER WENT INTO IJ AND THEN WHEN REPOSITIONED, SHERLOCK WOULD NOT CORRELATE POSITION WELL. REMOVED SHERLOCK WIRE TO RESET DEVICE. WIRE HAD A BEND IN THE TIP THAT WAS NOTICED WHEN IT WAS REMOVED AND THE TIP BROKE OFF COMPLETELY PRIOR TO BEING REINSERTED INTO THE PICC. WAS THE BARD PRODUCT USED ON A PATIENT?: YES. WAS THERE PATIENT HARM REPORTED?: NO. WIRE BROKE BEFORE BEING REINSERTED INTO PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757025 ↗
• MalfunctionMay 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR DILATOR SHEATHS IN THE 3FR POWERPICC PROVENA CATHETER TRAYS ARE "BURRING UP" WHEN ATTEMPTING TO INSERT. THIS REPORT ADDRESSES THE THIRD OF FOUR DILATORS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10030634 ↗
• MalfunctionMay 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR DILATOR SHEATHS IN THE 3FR POWERPICC PROVENA CATHETER TRAYS ARE "BURRING UP" WHEN ATTEMPTING TO INSERT. THIS REPORT ADDRESSES THE FOURTH OF FOUR DILATORS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10030616 ↗
• MalfunctionMay 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR DILATOR SHEATHS IN THE 3FR POWERPICC PROVENA CATHETER TRAYS ARE "BURRING UP" WHEN ATTEMPTING TO INSERT. THIS REPORT ADDRESSES THE SECOND OF FOUR DILATORS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10030614 ↗