PowerPICC Provena S1274108Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741130120), received between Nov 1, 2017 and Nov 7, 2024 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT PATIENT CAME FOR A DRESSING CHANGE AND TO CHANGE THE BROKEN CLAMP TO THE RED LUMEN. ACCORDING TO PATIENT, THE CLAMP HAS BEEN BROKEN FOR A WHILE BUT NURSE UNABLE TO CHANGE IT OUT DUE TO NO AVAILABILITY OF THE REPLACEMENT CLAMP. I REMOVED THE BROKEN CLAMP AND REPLACED WITH A NEW CLAMP WITHOUT ANY DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631511 ↗
• MalfunctionJan 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  BD VASCULAR ACCESS DEVICES FIELD ASSURANCE RECEIVED A LEAKING PICC FOR EVALUATION. A NOTE FROM THE CUSTOMER ATTACHED TO THE SAMPLE STATED PICC WAS INSERTED IN THE BASILIC VEIN. ADDITIONAL INFORMATION RECEIVED 1/24/2023: CUSTOMER REPORTS THE PATIENT HAD THE PICC REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261233 ↗
• MalfunctionJan 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "DURING PLACEMENT OF ANOTHER 4 FR. DUAL LUMEN PICC WE HAD A WIRE WITH A SIGNIFICANT BEND IN IT UPON REMOVAL FROM THE PATIENT. THE WIRE WAS INTACT." (B)(6) 2022: RETURNED STYLET WIRE IS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283248 ↗
• MalfunctionSep 23, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "A PICC LINE WAS PLACED FOR THIS PATIENT DUE TO THE NEED FOR TPN AND LONG TERM VENOUS ACCESS. THE LEFT UPPER EXTREMITY WAS CHOSEN FOR PICC PLACEMENT. THE VEIN WAS ACCESSED, A NITINOL GUIDEWIRE WAS PLACED AND A PEEL AWAY INTRODUCER WAS PLACED OVER THE GUIDEWIRE. THE GUIDEWIRE WAS REMOVED INTACT AND DISCARDED. THE PICC LINE WAS THEN THREADED THROUGH THE INTRODUCER, AFTER APPROX. 20 CM OF THE PICC LINE BEING INSERTED RESISTANCE WAS MET. THIS CAN BE A COMMON FINDING, I REPOSITIONED THE ARM MULTIPLE TIMES AS THIS CAN AID WITH PASSING THE CATHETER THROUGH TO THE SVC. AFTER MULTIPLE REPOSITIONING ATTEMPTS I WAS ABLE TO GET THE CATHETER TO PASS WITHOUT RESISTANCE, THE NAVIGATION SENSOR WE USE WAS SHOWING THAT THE CATHETER WAS TRAVELING THE PROPER DIRECTION, HOWEVER THE ECG TRACING THAT WE USE FOR DEFINITIVE PLACEMENT WAS ACTING UP, THE SIGNAL WAS NOT CONSISTENT. I MADE THE DECISION TO PULL THE 3CG WIRE/STYLET AND OBTAIN A CHEST FILM FOR DEFINITIVE PLACEMENT VERIFICATION. UPON REMOVING THE 3CG STYLET I NOTED THAT THE DISTAL END OF THE STYLET WAS DEFORMED AND THERE WAS A NOTICEABLE HARSH BEND IN THE WIRE 5 CM BACK FROM THE DISTAL TIP. I PHYSICALLY EXAMINED THE END OF THE STYL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520504 ↗
• MalfunctionAug 26, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT TWO GUIDEWIRE STYLETS BENT AND/OR FRACTURED OFF DURING PICC INSERTION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374046 ↗
• MalfunctionAug 26, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT TWO GUIDEWIRE STYLETS BENT AND/OR FRACTURED OFF DURING PICC INSERTION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374003 ↗
• MalfunctionAug 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT PICC REQUIRED REPLACEMENT DUE TO INTERNAL KINKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351419 ↗
• MalfunctionAug 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT PICC REQUIRED REPLACEMENT DUE TO INTERNAL KINKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351410 ↗
• MalfunctionMay 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT SOME MECHANICAL OCCLUSIONS ARE HAPPENING DUE TO KINKING OF THE LINES, PRIMARILY ON 4F DL AND 5F TL LINES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826711 ↗
• MalfunctionMay 9, 2018Break; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT NEEDED A PICC REPLACEMENT DUE TO A BREAK NEAR THE HUB OF THE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500687 ↗
• MalfunctionApr 5, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PICC LINE PLACEMENT, BLOOD STARTED COMING OUT OF THE PURPLE LUMEN EVEN THOUGH IT WAS CLAMPED. THEY CLAMPED IT AGAIN AND THEN OBTAINED A NEW CATHETER TO CONTINUE WITH THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7401460 ↗
• MalfunctionMar 23, 2018Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT WHEN THE VAS TEAM ARRIVED TO ASSESS THE PATIENT¿S PICC, THE PATIENT'S DRESSING HAD BEEN REMOVED AND THE LUMENS WERE WRAPPED IN AN ABDOMINAL PAD DUE TO LEAKING. IT WAS NOTED THAT IT WAS FRACTURED ¿WHERE THE TUBING ENTERS INTO THE END PORTION OF THE LUMENS¿ AND THAT THE FRACTURE WAS VISIBLE. IT WAS ALSO NOTED THAT ¿BLOOD WAS LEAKING OUT.¿ THE PICC WAS REMOVED AND A STERILE DRESSING WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367107 ↗
• MalfunctionFeb 7, 2018Break; Defective Device; Device Dislodged or Dislocated

  THE FACILITY REPORTED THE NIGHT SHIFT WAS CALLED LAST NIGHT FOR A DEFECTIVE PICC. ON ARRIVAL VAST IT WAS FOUND THAT THE PORT WAS "HANGING BY A THREAD". IT WAS STATED WHEN THE NURSE PULLED IT OUT, THE END BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7250187 ↗
• MalfunctionFeb 6, 2018Break

  THE FACILITY REPORTED THE PICC WAS REMOVED AND REPLACED DUE TO A HUB/CATHETER BREAK. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246316 ↗
• MalfunctionFeb 6, 2018Break; Fluid/Blood Leak

  THE FACILITY REPORTED THE CATHETER WAS REPLACED DUE TO BREAK/LEAK AT THE HUB. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246314 ↗
• MalfunctionFeb 6, 2018Detachment Of Device Component

  THE FACILITY REPORTED THAT THE "CAP CAME OF THE PICC PORT". THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246311 ↗
• MalfunctionFeb 6, 2018Fluid/Blood Leak

  THE FACILITY REPORTED THE CATHETER WAS REPLACED DUE TO BREAK/LEAK AT THE HUB. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246259 ↗
• MalfunctionJan 4, 2018Crack; Chemical Spillage

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED A CRACK IN THE HUB OF A PROVENA. THE SALES REP STATED THAT CHEMO LEAKED EVERYWHERE INCLUDING "ONTO THE PATIENT". THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7164181 ↗
• MalfunctionJan 3, 2018Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THE PICC WAS PLACED ON (B)(6) 2017. ON (B)(6) 2017, IT WAS DISCONNECTED AS A LEAK WAS FOUND BENEATH THE RED HUB AND EXTENSION JUNCTURE. PATIENT WAS ON "VASOSUPRESSORS" AND COULDN'T KEEP HIS BLOOD PRESSURE UP. WHEN TRACING THE IV TUBING BACK TO THE PICC, IT WAS NOTED THAT THE MEDICATION WAS LEAKING ONTO THE BED AND THE PATIENT WASN'T RECEIVING MEDICATION.

  Patient problems: Underdose

  MAUDE report 7162840 ↗
• MalfunctionDec 14, 2017Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED HAVING A PICC LINE THAT WAS LEAKING FROM THE RED HUB THAT CONNECTED TO THE EXTENSION LEG. THE SALES REP STATED THAT THERE WAS NO VISIBLE CRACK. IT WAS REPORTED THAT ONLY ONE LEG WAS USED, AS THEY DID NOT NEED THE DUAL LUMEN AND THE LINE WAS PULLED UPON COMPLETION OF THERAPY. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7118125 ↗
• MalfunctionDec 14, 2017Fluid/Blood Leak

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED HAVING A PICC LINE THAT WAS LEAKING FROM THE PURPLE HUB THAT CONNECTED TO THE EXTENSION LEG. THE SALES REP STATED THAT THERE WAS NO VISIBLE CRACK. IT WAS REPORTED THAT ONLY ONE LEG WAS USED, AS THEY DID NOT NEED THE DUAL LUMEN AND THE LINE WAS PULLED UPON COMPLETION OF THERAPY. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7118005 ↗
• MalfunctionNov 1, 2017Hole In Material; Leak/Splash

  THE FACILITY REPORTED THAT THE PROVENA CATHETER LEAKED FROM A PINHOLE BETWEEN THE HUB AND TUBING. THE LINE WAS REMOVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6993882 ↗