PowerPICC Provena S1294108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741155208), received between Sep 3, 2020 and May 29, 2026 — classified as 1 death, 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Crack

  IT WAS REPORTED THAT THE PICC TEAM WAS PLACING A DOUBLE LUMEN PICC, THEY NOTED THAT THE RED PORT HAD CRACKED WHEN THEY ATTACHED TO SALINE FLUSH TO IT. NO PATIENT HARM. PICC ENDED UP NEEDING TO BE OVER WIRED TO A NEW PICC DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333460 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC LEAKING FROM THE SOLO VALVE WHEN FLUSHED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966947 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC IS LEAKING FROM THE SOLO VALVE WHEN FLUSHED. DISCOVERED PRIOR TO PLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966313 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC IS LEAKING FROM THE SOLO VALVE WHEN FLUSHED. DISCOVERED PRIOR TO PLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953552 ↗
• InjuryFeb 3, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, WHEN USING THE GREEN INTRODUCER NEEDLE, THE RN RETRACTED THE NEEDLE FROM PATIENT AND WENT TO PUSH UP THE SAFETY PORTION TO "SAFETY" THE NEEDLE, THE SAFETY PORTION FELL OFF. THE RN ACCIDENTALLY PRICKED HERSELF WITH THE NEEDLE RESULTING IN A NEEDLESTICK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21299937 ↗
• MalfunctionJan 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN INSERTING THE NEEDLE INTO THE NEEDLE GUIDE, THE PLASTIC PIECE OF THE NEEDLE GUIDE HASN'T BEEN FULLY PERFORATED, SO THE RN HAS TO ADVANCE THE NEEDLE GUIDE AND JAM IT THROUGH TO OPEN THE SLIT OF THE NEEDLE GUIDE. THIS IS CAUSING PLASTIC PARTICLES TO GET STUCK IN THE NEEDLE THAT THEY ULTIMATELY HAVE TO INSERT INTO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118339 ↗
• MalfunctionDec 19, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE GREEN CAP FOR THE PICC NEEDLE SLID ALL THE WAY OFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20981616 ↗
• MalfunctionOct 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT MICROINTRODUCER FROM A PICC THAT WHEN A COWORKER WAS ATTEMPTING TO INSERT INTO PTS VEIN WAS NOT ABLE TO ADVANCE. AFTER REMOVED I LOOKED AT IT AND NOTICED THE END OF THE EXTERNAL SHEATH WAS NOT SMOOTH. NOT SURE IF WAS LIKE THAT PRIOR TO INSERTING ATTEMPT OR NOT. NO INJURY TO PATIENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514047 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER PICC WAS PLACED AROUND 0730 BY RN. NO ISSUES WITH PICC PLACEMENT. RN GOT A CALL AROUND 1700 FROM THE ICU NURSE STATING ISSUES WITH THE NEW PICC. STATED THAT WHEN HE WENT TO FLUSH ONE OF THE PICC LUMENS AFTER A BLOOD DRAW, THE INITIAL 5CC WENT IN BUT THE REST OF THE SALINE AND SLUGGISH BLOOD STARTED COMING OUT OF THE SECOND LUMEN. WHEN PLACEMENT RN WENT TO ASSESS THE LINE, SHE STATED THE SAME THING HAPPENING TO HER. SHE FLUSHED THE PURPLE LUMEN JUST FIND WITH NO ISSUES, THEN ASPIRATED AND FLUSHED AGAIN WITH THE SECOND FLUSH WHEN BLOOD STARTED COMING OUT OF THE OTHER LUMEN. NO LEAKING WAS NOTED. THE PICC WAS REMOVED AND LEAKING/POSSIBLE FRACTURE IS SOMEWHERE IN THE MIDDLE OF THE PICC BUT UNABLE TO LOCATE. A NEW LINE PLACED. PATIENT WAS RECEIVING Q4HR BLOOD DRAWS. RN STATED NO ISSUES UP UNTIL THE 3RD LAB DRAW. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156843 ↗
• MalfunctionApr 11, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE PICC NEEDED TO BE EXCHANGED DUE TO KINKING. X-RAYS TAKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087469 ↗
• DeathSep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDWATCH ¿ON (B)(6), 2021, MY HUSBAND WAS ADMITTED AS A FULL CODE TO (B)(6) MEDICAL CENTER WITH COVID PNEUMONIA. FROM (B)(6), 2021, HE WAS KEPT IN ISOLATION FOR AIRBORNE PRECAUTIONS IN THE INTENSIVE CARE UNIT'S COVID SECTION. ON (B)(6), 2021, THE HOSPITAL STAFF INSERTED A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) INTO HIS RIGHT UPPER EXTREMITY. DUE TO A LACK OF AVAILABLE BEDS IN THE MEDICAL-SURGICAL UNIT, THE HOSPITAL STAFF KEPT MY HUSBAND IN ISOLATION IN THE ICU'S COVID SECTION FOR AN ADDITIONAL THREE DAYS (NOTE: (B)(6), 2021), EVEN THOUGH HE HAD TESTED NEGATIVE FOR COVID. THIS EXTENDED EXPOSURE TO THE COVID VIRUS CONCERNED ME BECAUSE OF HIS INCREASED RISK FOR RE-INFECTION. ON THE EVENING OF (B)(6), 2021, HE WAS TRANSFERRED TO THE MEDICAL-SURGICAL UNIT. AFTER ARRIVAL AND ASSESSMENT, HIS NURSE, (B)(6), RN, RECORDED IN HIS CHART THAT HIS PICC WAS IN HIS LEFT UPPER EXTREMITY AND NOT HIS RIGHT. (NOTE: THE PICC WAS ALWAYS IN HIS RIGHT UPPER EXTREMITY UNTIL (B)(6), 2021.) ON THE AFTERNOON OF (B)(6), 2021, HE WAS TRANSFERRED BACK TO THE ICU, PLACED ON STANDARD PRECAUTIONS, AND NOT ALLOWED TO HAVE ANYTHING TO EAT OR DRINK BY MOUTH. WHEN I SAW MY HUSBAND IN THE ICU,

  Patient problems: Bruise/Contusion; Sepsis; Swelling/ Edema

  MAUDE report 17794882 ↗
• MalfunctionJul 27, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT SALINE LEAKS FROM T LOCK AREA ECG AND SEPTUM AREA. ADDITIONAL INFORMATION FROM CUSTOMER RESPONSE ON 7-19-2023: IT WAS REPORTED "WE NOTICED THAT WHEN WE WENT TO FLUSH THE PICC LINE, THE FLUSH WOULD COME OUT AROUND THE WIRE ON THE END CAP INSTEAD OF FLUSHING THE LINE. WE HAVE NOTICED THIS ON MANY PICC LINES. WE WOULD PUT OUR FINGER OVER THE END CAP TO FLUSH." CUSTOMER REPORTED THIS HAS HAPPENED ON MANY LINES HOWEVER THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED TO BD VASCULAR ACCESS DEVICES FIELD ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17407178 ↗
• InjuryJul 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CUSTOMER REPORTED "THERE HAS BEEN A PATIENT EVENT WITH HARM DUE TO INADVERTENT ARTERIAL PICC PLACEMENT. WE WOULD LIKE BD TO ADDRESS WHY THE SHERLOCK/3CG TECHNOLOGY WOULD SHOW AN INCREASE IN P-WAVE AMPLITUDE TO INDICATE THAT THE TIP WAS IN THE CORRECT POSITION, EVEN IF THE PICC WAS ACTUALLY IN THE ARTERIAL SYSTEM. IN THE PATIENT EVENT WHEN 3CG TECHNOLOGY WAS USED TO CONFIRM PROPER PICC TIP PLACEMENT, THE ECG STRIPS MET CRITERIA FOR RELEASING THE PICC FOR USE. THE PICC WAS LATER CONFIRMED BY OTHER MEASURES TO BE ARTERIAL INSTEAD OF VENOUS. THE SITUATION HAS BEEN EXTENSIVELY REVIEWED VIA OUR INSTITUTIONAL QUALITY AND PATIENT SAFETY PROCESS. PICC RNS HAVE RECEIVED REFRESHER EDUCATION AND OPPORTUNITIES TO ENHANCE PATIENT SAFETY ARE BEING EXPLORED." PICC REMOVED BY VASCULAR SURGEON.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 17330941 ↗
• MalfunctionNov 22, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "WHEN I PULLED OUT THE WIRE, IT WAS DANGLING AT A 90° ANGLE, AND PULLED OFF WHEN CLEANING WIRE. I DID NOT CLIP THE 3CG WIRE WHEN CUTTING THE PICC TO CORRECT LENGTH, BECAUSE I PULLED THE WIRE ALMOST ENTIRELY OUT PRIOR TO TRIMMING THE PICC. THE INSERTION WAS SMOOTH AND HAD NO COMPLICATIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15844755 ↗
• MalfunctionAug 29, 2022Break; Difficult or Delayed Positioning; Entrapment of Device; Material Deformation

  PICC LINE IN THE SPECIAL NEEDS PATENT IT WAS NOT A DIFFICULT PLACEMENT BUT DID HAVE SOME DIFFICULTY GETTING IN DOWN INTO THE SVC. THE TIP OF THE PICC PER THE SHERLOCK IMAGE WENT STRAIGHT ACROSS OR CURVED BACK ON ITSELF A FEW TIMES BEFORE DESCENDING INTO THE SVC. BECAUSE OF THE SPECIAL NEEDS ASPECT OF THE PATIENT AND PHYSICAL ATTRIBUTES THE PICC LINE HAD TO BE REMOVED AND TRIMMED 3 TIMES TOTAL TO ACHIEVE PROPER LENGTH. BUT IT WENT DOWN INTO THE PROPER SVC PLACEMENT. AFTER PLACING THE LINE I WAS PUTTING THE DRESSING ON AND GATHERING MY SHARPS WHEN I NOTICE THE TIP OF THE 3CG STYLET WAS NOT INTACT. I QUICKLY WITHDREW 10 ML BLOOD HOPING IT WOULD WITHDRAW THE TIP IF IT WAS STILL IN THE PICC LINE ITSELF, TO NO SUCCESS. I HAD ALREADY FLUSHED THE LINE AS PART OF THE CONFORMATION PROCEDURE FOR PLACE THE PICC LINE. I DID CAREFULLY LOOK AROUND ON MY STERILE FIELD TO SEE IF I COULD SEE THE TIP BUT DID NOT SEE IT. IT APPEARS APPROXIMATELY 3 CM IS MISSING WHEN COMPARED TO AN INTACT 3CG STYLET. I FINISHED THE REMANDED OF THE PROCEDURE. I NOTIFIED THE NURSE AND REQUESTED A PCXR, WHICH WAS DONE AND ALSO TALKED WITH PROVIDER. THE CHEST XR DID SHOW A POSSIBLE METALLIC OBJECT AND RECOMMENDED A CT FOR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15321272 ↗
• MalfunctionAug 9, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED " I NEVER GOT A 3CG RHYTHM SIGNAL DURING INSERTION OF DOUBLE LUMEN PICC. I ADJUSTED SETTINGS FOR 3CG RHYTHM SIZE AND BASELINE HEIGHT. NEVER SAW A GRAPHICAL 3CG RHYTHM ON SCREEN. WHEN I PULLED OUT THE WIRE, IT WAS DANGLING AT A 90° ANGLE, AND PULLED OFF WHEN CLEANING WIRE TO SEND TO BD. I DID NOT CLIP THE 3CG WIRE WHEN CUTTING THE PICC TO CORRECT LENGTH, BECAUSE I PULLED THE WIRE ALMOST ENTIRELY OUT PRIOR TO TRIMMING THE PICC. THE INSERTION WAS SMOOTH AND HAD NO COMPLICATIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196105 ↗
• MalfunctionFeb 10, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED ¿GS PLACED PICC YESTERDAY BUT WHEN TRIED TO FLUSH IT WOULD NOT. THEY HAD FLUSHED PRIOR TO INSERT. WHEN THEY REMOVED THEY FOUND PIECE OF PLASTIC AT 10-11 CM." ADD INFO RCVD (B)(6) 2022: PLACEMENT INFO: "GS PLACED PICC YESTERDAY BUT WHEN TRIED TO FLUSH IT WOULD NOT. THEY HAD FLUSHED PRIOR TO INSERT. WHEN THEY REMOVED THEY FOUND PIECE OF PLASTIC AT 10 11 CM." WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507470 ↗
• MalfunctionDec 22, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "YESTERDAY AN PICC KIT WAS OPENED FOR INSERTION AND THERE WAS A HAIR FOUND IN THE STERILE KIT WRAPPED AROUND THE BRAUN INTROCAN WRAPPER. DISPOSED OF THE ENTIRE KIT DUE TO POSSIBLE CONTAMINATION FROM THE HAIR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060386 ↗
• MalfunctionDec 8, 2021Defective Component; Defective Component

  IT WAS REPORTED "¿OUR PICC NURSE HAS A SAFETY CONCERN SHE BROUGHT UP TO US TODAY ABOUT THE NEEDLE GUIDE THAT IS IN THE PICC KITS. SHE IS SAYING THERE IS A SMALL PLASTIC PIECE THAT COMES OFF THE TIP OF THE NEEDLE WHEN THEY ARE POKING THE GUIDE THROUGH THE SKIN. THEY ARE WORRIED ABOUT THE PATIENT GETTING A CLOT. SHE CURRENTLY IS BRUSHING THE PLASTIC PART OFF AS IT COMES OFF NOW BUT IT SHOULDN¿T BE COMING OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964076 ↗
• MalfunctionDec 8, 2021Defective Component; Defective Component

  IT WAS REPORTED "OUR PICC NURSE HAS A SAFETY CONCERN SHE BROUGHT UP TO US TODAY ABOUT THE NEEDLE GUIDE THAT IS IN THE PICC KITS. SHE IS SAYING THERE IS A SMALL PLASTIC PIECE THAT COMES OFF THE TIP OF THE NEEDLE WHEN THEY ARE POKING THE GUIDE THROUGH THE SKIN. THEY ARE WORRIED ABOUT THE PATIENT GETTING A CLOT. SHE CURRENTLY IS BRUSHING THE PLASTIC PART OFF AS IT COMES OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964044 ↗
• MalfunctionDec 1, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED "CUSTOMER IS EXPERIENCING PRESSURE LIMITING ON 4FR SINGLE POWERPICC SOLO." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909173 ↗
• MalfunctionDec 1, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED "CUSTOMER IS EXPERIENCING PRESSURE LIMITING ON 4FR DUAL PROVENA SOLO PICC." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909001 ↗
• MalfunctionJun 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A CATHETER KINKING. THE KINKING IS HAPPENING AT THE INSERTION SITE, BUT WITHIN THE PATIENT. IT WAS STATED THE KINKED CATHETER WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008603 ↗
• MalfunctionJun 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE FACILITY IS EXPERIENCING AN INCREASE IN CATHETER KINKING. THE KINKING IS HAPPENING AT THE INSERTION SITE, BUT WITHIN THE PATIENT. CATHETERS WERE DISCARDED ONCE REMOVED. IT IS UNKNOWN HOW MANY CATHETERS HAVE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008589 ↗
• MalfunctionOct 14, 2020Malposition of Device

  IT WAS REPORTED THE PICC WAS INSERTED (B)(6) 2020 ON R BRACHIAL, MALPOSITION (B)(6) 2020, REPLACED (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10677136 ↗