PowerPICC Provena SOLO S1295108FD3Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741155017), received between Feb 8, 2019 and Aug 28, 2023 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT BARD POWER PICC THAT WAS PLACED IN A PATIENT NEVER USED AND ON DAY 5 POST PLACEMENT HAD A HOLE IN IT NEAR THE HUB. ADDITIONAL INFORMATION 24AUG2023: PICC PLACED (B)(6) 2023 FOR CHEMOTHERAPY AS AN OUTPATIENT USING SHERLOCK 3CG. THE EVENT WAS NOT LIFE THREATENING, HOWEVER, THE PATIENT DID HAVE TO HAVE THIS PICC REMOVED AND ANOTHER ONE PLACED. ON (B)(6) 2023 THE PATIENT REPORTED FOR BLOOD DRAW AND LAB NURSE NOTICED THAT SALINE WAS SEEPING OUT OF THE BASE OF THE HUB ON THE PICC LINE WHILE FLUSHING. CALLED THE STAT NURSE TO COME DOWN TO INSPECT THE SITE. STAT RN CHANGED THE DRESSING AND PLACED A "DO NOT USE" LABEL ON PICC LINE AND EDUCATED THE PATIENT TO NOT USE THE LINE FOR ANY BLOOD DRAWS OR INFUSIONS UNTIL FURTHER NOTICE. PATIENT STATED HE UNDERSTOOD AND AGREED. STAT RN WILL CALL TEAM RN AND COMMUNICATE WITH THE TEAM ABOUT THE DEFECTED PICC LINE. LABS WERE DRAWN PERIPHERALLY. WILL CONTINUE TO MONITOR. ON (B)(6) 2023 PICC REMOVAL WAS ORDERED. PRE-PROCEDURE DIAGNOSES: MDS (MYELODYSPLASTIC SYNDROME) (HCC) [D46.9]. POST-PROCEDURE DIAGNOSES: MDS (MYELODYSPLASTIC SYNDROME) (HCC) [D46.9]. PICC WAS REMOVED (B)(6) 2023 AT 12:50 PM. PATIENT GAVE VERBAL CONSENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638572 ↗
• MalfunctionJun 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "INTRODUCER IN KIT HAD A LIP AT THE TIP THAT WOULDN'T ALLOW TO INSERT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14650457 ↗
• MalfunctionMay 21, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED "ACCOUNT REPORTS PLACING PICC WITH NO ISSUES. REPORTS USING SHERLOCK 3CG WITH TIP CONFIRMATION, SHOWED "PERFECT 3CG GREEN DIAMOND, NO DEFLECTION AND GOT CHEST XRAY AND THEY WERE DEEP. 4-6 CM TOO DEEP." NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465311 ↗
• MalfunctionJan 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "MICRO-INTRODUCER SHEATH BENDING WHILE ATTEMPTING TO ADVANCE DEVICE INTO BLOOD VESSEL. CLINICIAN REPORTS FEELING DISTINCT "POP" AS MICRO-INTRODUCER PASSES THROUGH SUBCUTANEOUS LAYER BUT THEN UNABLE TO PASS THROUGH BLOOD VESSEL WALL ON 1 OCCASION AS SHEATH BEGINS BENDING. CLINICIAN THEN RETRACTED MICRO-INTRODUCER, REMOVED PEEL AWAY SHEATH, INSERTED DILATOR OVER WIRE INTO TARGET VESSEL, RETRACTED DILATOR AND RE-ASSEMBLED WITH PEEL-AWAY SHEATH, THEN SUCCESSFULLY PASSED MICRO-INTRODUCER OVER WIRE INTO TARGET VESSEL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236493 ↗
• MalfunctionMay 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STAFF HAS BEEN EXPERIENCING ISSUES WITH THEIR INTRODUCERS. ADDITIONAL INFORMATION RECEIVED 02/03/2021: ISSUES WERE EXPERIENCED ADVANCING THE INTRODUCER. IT WAS GETTING HUNG AND BENDING. AN ALTERNATIVE INTRODUCER WAS USED. NO OTHER INFORMATION WAS PROVIDED. 04/20/2021: THE DISTAL TIP OF THE RETURNED SAMPLE WAS OBSERVED TO BE DAMAGED WITH EVIDENCE OF BUCKLING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814057 ↗
• MalfunctionMar 5, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "WHILE RN WAS ADVANCING THE PICC, RESISTANCE WAS MET AT SOME POINT AFTER PASSING THE SHOULDER. THE INTRODUCER WAS STILL IN. ELEVATED P-WAVES WERE SEEN ON 3CG. RN REMOVED THE STYLET TO MAKE THE PICC TIP FLOPPY, HE ADVANCED THE PICC AND WAS ABLE TO ADVANCE IT WITHOUT ISSUE. HE REINSERTED THE STYLET AND FELT RESISTANCE BUT WAS ABLE TO REINSERT ALL THE WAY. HE FLUSHED IT BUT WAS UNABLE TO SEE ANY INTERNAL ECG TRACING; THE YELLOW LINE WAS ALSO GONE. HE TRIED DISCONNECTING AND RECONNECTING THE WHITE CLIP THAT IS CONNECTED TO THE PICC AND MAKES THE THROUGH-THE-DRAPE CONNECTION TO THE SHERLOCK FIN TO SEE IF THAT WOULD BRING THE ECG TRACING BACK BUT IT DID NOT. RN BROKE AWAY THE INTRODUCER AND ADVANCED THE WHOLE PICC IN. WHEN HE REMOVED THE STYLET, HE NOTICED THAT THE WIRE WAS ALMOST BROKEN IN HALF. HE HELD IT UP FOR HIS CO-WORKER TO TAKE A PHOTO AND THE TIP OF THE WIRE FELL OFF RIGHT AFTERWARDS. A CXR WAS OBTAINED SHOWING A BRACHIOCEPHALIC/CONTRALATERAL PLACEMENT FROM THE RIGHT SIDE COURSING OVER TO THE LEFT SUBCLAVIAN. RN TRIED TO POWER FLUSH IT DOWN WHICH DIDN¿T WORK. OTHER RN THEN ATTEMPTED A CATHETER EXCHANGE IN WHICH THE SHERLOCK LOLLIPOP SHOWED THE TIP GOING DOWN AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426159 ↗
• MalfunctionAug 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED "NURSE FELT RESISTANCE UPON INSERTION OF MICROINTRODUCER. DARK GREY PEEL AWAY PORTION OF INTRODUCER WAS BUNCHED UP WHEN NURSE REMOVED THE MICROINTRODUCER FROM SKIN. NURSE PULLED A LONGER 5F X 10CM RADSTIC INTRODUCER AND HAD NO ISSUES WITH INSERTION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462976 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC KINKED IN THE PATIENTS ARM, RESTRICTING THE ABILITY TO FLUSH OR DRAW THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314526 ↗
• MalfunctionJul 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC KINKED IN THE PATIENTS ARM, RESTRICTING THE ABILITY TO FLUSH OR DRAW THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314082 ↗
• InjuryMar 19, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ATTEMPT TO PLACE A 5 FR DUAL LUMEN PICC ON A PATIENT IN THE ICU, SOME DIFFICULTY WAS HAD GETTING THE GUIDEWIRE TO DROP INTO THE SVC LEADING TO A LEFT IJ PLACEMENT VERIFIED BY X-RAY, THE CATHETER WAS REMOVED AFTER X-RAY. DURING IMAGING IT WAS NOTED THAT THERE WAS A FOREIGN OBJECT IN THE RIGHT VENTRICLE OF THE HEART DETERMINED TO BE A PORTION OR THE TIP OF THE PICC GUIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9857812 ↗
• MalfunctionApr 3, 2019Separation Problem

  IT WAS REPORTED THAT THE INTRODUCER FAILED TO BREAK AWAY WHILE INSERTING A PICC LINE. IT WAS REMOVED WITH FORCEP-ASSISTED AND PICC WAS PLACED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480385 ↗
• MalfunctionFeb 8, 2019Material Discolored

  IT WAS REPORTED THAT THE EXTENSION LEG TUBING TURN BLACK ON BOTH LUMENS. IT WAS STATED THE ONLY MEDICATIONS THAT WERE INFUSED WERE CEFTRIAXONE 2G QHS AND NS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323206 ↗