PowerPICC Provena S1173108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741155031), received between Apr 25, 2019 and Sep 15, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Defective Component” (13 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak

  It was reported by the customer that the PICC line was leakage.Caller contacted Medical Information with questions regarding how to schedule her medication doses. Caller reported that her PICC line was evaluated in the ER the previous night due to leakage. Caller stated that, as a result, her medication schedule has been disrupted, and she is seeking guidance on how to resume treatment.Advised the caller to contact her prescribing provider, home infusion pharmacy, or home health nurse for guidance on adjusting her medication schedule. Also advised the caller to have her PICC line evaluated, as she reported visiting the ER the previous night due to a leaking PICC line. During that visit, an additional piece was added to the PICC line. The caller stated that she was unable to flush the PICC line today. The caller reported that a home health nurse was enroute to her residence to assess the PICC line and provide assistance.Additional information received 02Sep2026; Followed up with HCP, went to Oncologist Fri (b)(6)2026 before the leakage and scheduled for bloodwork. PT went to ER on (b)(6) for the leakage and ER RN replaced tubing that was leaking and added extender. Then the schedule

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773782 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE DILATOR IS BUCKLING AT THE SKIN EVEN WITH A NICK AT THE SITE, CAUSING THE GRAY PART TO PUSH BACK AND CRUMBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417718 ↗
• MalfunctionJul 21, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED, WHEN REMOVING PEEL AWAY INTRODUCER LEFT HAND GRAY PIECE BROKE OFF OF THE INTRODUCER. RIGHT HAND INTRODUCER PIECE STILL HOLDING ON AND ABLE TO REMOVE INTRODUCER ALL IN ONE PIECE. THERE WAS NO PATIENT HARM FROM THE INCIDENT. THE INSERTER INTELLIGENTLY PULLED THE PICC WITH INTRODUCER BACK FAR ENOUGH HE COULD USE OTHER SIDE OF THE INTRODUCER TO PULL IT APART AND REINSERT THE PICC A COUPLE CENTIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559703 ↗
• MalfunctionAug 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THE DILATORS IN THE 3FR PICC KITS ARE VERY FLIMSY AND DIFFICULT TO FEED THROUGH TISSUE. THE DARK MATERIAL OF THE OUTER DILATOR OFTEN "CRINKLES" UP OR A SMALL PIECE ON THE TOP WILL START TO PEEL BACK, CREATING A KIND OF HANG NAIL AS YOU'RE TRYING TO FEED IT INTO THE VESSEL, AND TYPICALLY UNABLE TO SUCCESSFULLY PLACE THE DILATOR. TODAY, AS I WAS TRYING TO PLACE A 3FR PICC ON A 13-MONTH-OLD. I INITIALLY TRIED SEPARATING THE INNER AND OUTER DILATOR AND FEEDING THE INNER DILATOR THROUGH FIRST, ALLOWING THE VESSEL SOME TIME TO STRETCH AND RELAX. I ALSO MADE A VERY SMALL SUPERFICIAL DERMATOTOMY TO DECREASE RESISTANCE ON THE OUTER DILATOR BUT NONE OF THOSE TRICKS MADE THE DIFFERENCE AND THE PLASTIC ON THE END CURLED BACK ANYWAY. I ENDED UP HAVING TO USE A DILATOR FROM A 4.5FR MICRO KIT." THE CUSTOMER REPORTED THIS AS AN ONGOING OCCURRENCE HOWEVER DID NOT PROVIDE AN EXACT QUANTITY. THIS FILE WILL ADDRESS THE UNKNOWN EVENT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971840 ↗
• MalfunctionAug 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THE DILATORS IN THE 3FR PICC KITS ARE VERY FLIMSY AND DIFFICULT TO FEED THROUGH TISSUE. THE DARK MATERIAL OF THE OUTER DILATOR OFTEN "CRINKLES" UP OR A SMALL PIECE ON THE TOP WILL START TO PEEL BACK, CREATING A KIND OF HANG NAIL AS YOU'RE TRYING TO FEED IT INTO THE VESSEL, AND TYPICALLY UNABLE TO SUCCESSFULLY PLACE THE DILATOR. TODAY, AS I WAS TRYING TO PLACE A 3FR PICC ON A 13 MONTH OLD. I INITIALLY TRIED SEPARATING THE INNER AND OUTER DILATOR AND FEEDING THE INNER DILATOR THROUGH FIRST, ALLOWING THE VESSEL SOME TIME TO STRETCH AND RELAX. I ALSO MADE A VERY SMALL SUPERFICIAL DERMATOTOMY TO DECREASE RESISTANCE ON THE OUTER DILATOR BUT NONE OF THOSE TRICKS MADE THE DIFFERENCE AND THE PLASTIC ON THE END CURLED BACK ANYWAY. I ENDED UP HAVING TO USE A DILATOR FROM A 4.5FR MICRO KIT." THIS FILE ADDRESSES THE 13 MONTH OLD PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971828 ↗
• InjuryJun 30, 2024Fluid/Blood Leak; Activation Problem; Fluid/Blood Leak; Activation Problem

  IT WAS REPORTED THAT CLINICIAN GOT SPRAYED IN THE FACE WITH BLOOD WHILE SECURING THE GREEN NEEDLE IN PICC KIT. AFTER THE WIRE WAS IN THE PATIENT, SHE PULLED THE NEEDLE, POINTED IT AWAY FROM HER OVER THE TRAY, AND PULLED DOWN THE GUARD TO LOCK IT AND IT SPRAYED BACK. ADDITIONAL INFORMATION 06/24/2024: IT WAS REPORTED THAT THE ISSUE IS THAT THE GREEN TOP NEEDLE SPRAYED BLOOD DURING NEEDLE SECUREMENT. IT LANDED ON MY FACE, BUT I WAS PROTECTED BY MY GLASSES AND MASK. WE ARE UNSURE WHY THIS HAPPENED. THERE WERE NO ADVERSE EVENTS JUST A NEAR MISS. THERE WAS NO PATIENT IMPACT. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 19641055 ↗
• MalfunctionApr 29, 2024Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE INSERTING A SINGLE LUMEN PICC LINE POWERPICC PROVENA, THERE WAS AIR BEING DRAWN THROUGH TRACKING WIRE GROMMET AND DIFFICULTY FLUSHING DUE TO SALINE ALSO ESCAPING FROM GROMMET RUBBER WHERE TRACKING WIRE ENTERS. MOST CONCERNING WAS THAT THERE WAS VISIBLE AIR BEING DRAWN INTO THE PICC CATHETER DURING THE INSERTION PROCESS FROM TRACKING WIRE GROMMET. ADVERSE EVENT WAS AVOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209633 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER DEFECTIVE PICC LINES. THERE ARE 6 PICC LINES 6 LINES LOT# REHR0323 WITH INSERTION DATES FROM 7/20-7/28 COLLECTED. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON 22/NOV/2023 EACH OF THESE EVENTS OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT REMAINS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND AT TIMES DURING FLUSHING. IT ALSO IS SO LOOSE AT TIMES THAT THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. ALTHOUGH SO FAR, THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THIS APPEARS TO BE A CRITICAL FAILURE POINT WITH RISKS THAT INCLUDE BUT ARE NOT LIMITED TO UNINTENTIONAL AIR EMBOLISM ADMINISTRATION, TRACKING WIRE MIGRATION, AND VESSEL PERFORATION. FORTUNATELY, THERE WERE NO PATIENTS INJURED DURING ANY OF THE PROCEDURES. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECKIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304542 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER DEFECTIVE PICC LINES. THERE ARE 6 PICC LINES 6 LINES LOT# REHR0323 WITH INSERTION DATES FROM 7/20-7/28 COLLECTED. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON 22/NOV/2023 EACH OF THESE EVENTS OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT REMAINS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND AT TIMES DURING FLUSHING. IT ALSO IS SO LOOSE AT TIMES THAT THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. ALTHOUGH SO FAR, THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THIS APPEARS TO BE A CRITICAL FAILURE POINT WITH RISKS THAT INCLUDE BUT ARE NOT LIMITED TO UNINTENTIONAL AIR EMBOLISM ADMINISTRATION, TRACKING WIRE MIGRATION, AND VESSEL PERFORATION. FORTUNATELY, THERE WERE NO PATIENTS INJURED DURING ANY OF THE PROCEDURES. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECKIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304511 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER DEFECTIVE PICC LINES. THERE ARE 6 PICC LINES 6 LINES LOT# REHR0323 WITH INSERTION DATES FROM (B)(6). COLLECTED. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON (B)(6). 2023 EACH OF THESE EVENTS OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT REMAINS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND AT TIMES DURING FLUSHING. IT ALSO IS SO LOOSE AT TIMES THAT THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. ALTHOUGH SO FAR, THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THIS APPEARS TO BE A CRITICAL FAILURE POINT WITH RISKS THAT INCLUDE BUT ARE NOT LIMITED TO UNINTENTIONAL AIR EMBOLISM ADMINISTRATION, TRACKING WIRE MIGRATION, AND VESSEL PERFORATION. FORTUNATELY, THERE WERE NO PATIENTS INJURED DURING ANY OF THE PROCEDURES. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304468 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER DEFECTIVE PICC LINES. THERE ARE 6 PICC LINES 6 LINES LOT# REHR0323 WITH INSERTION DATES FROM (B)(6) 2023 COLLECTED. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023 EACH OF THESE EVENTS OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT REMAINS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND AT TIMES DURING FLUSHING. IT ALSO IS SO LOOSE AT TIMES THAT THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. ALTHOUGH SO FAR, THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THIS APPEARS TO BE A CRITICAL FAILURE POINT WITH RISKS THAT INCLUDE BUT ARE NOT LIMITED TO UNINTENTIONAL AIR EMBOLISM ADMINISTRATION, TRACKING WIRE MIGRATION, AND VESSEL PERFORATION. FORTUNATELY, THERE WERE NO PATIENTS INJURED DURING ANY OF THE PROCEDURES. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304444 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER DEFECTIVE PICC LINES. THERE ARE 6 PICC LINES 6 LINES LOT# REHR0323 WITH INSERTION DATES FROM (B)(6) COLLECTED. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON 22/NOV/2023 EACH OF THESE EVENTS OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT REMAINS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND AT TIMES DURING FLUSHING. IT ALSO IS SO LOOSE AT TIMES THAT THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. ALTHOUGH SO FAR, THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THIS APPEARS TO BE A CRITICAL FAILURE POINT WITH RISKS THAT INCLUDE BUT ARE NOT LIMITED TO UNINTENTIONAL AIR EMBOLISM ADMINISTRATION, TRACKING WIRE MIGRATION, AND VESSEL PERFORATION. FORTUNATELY, THERE WERE NO PATIENTS INJURED DURING ANY OF THE PROCEDURES. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECKING T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304435 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER DEFECTIVE PICC LINES. THERE ARE 6 PICC LINES 6 LINES LOT# REHR0323 WITH INSERTION DATES FROM 7/20-7/28 COLLECTED. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED ON 22/NOV/2023. EACH OF THESE EVENTS OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT REMAINS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND AT TIMES DURING FLUSHING. IT ALSO IS SO LOOSE AT TIMES THAT THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. ALTHOUGH SO FAR, THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THIS APPEARS TO BE A CRITICAL FAILURE POINT WITH RISKS THAT INCLUDE BUT ARE NOT LIMITED TO UNINTENTIONAL AIR EMBOLISM ADMINISTRATION, TRACKING WIRE MIGRATION, AND VESSEL PERFORATION. FORTUNATELY, THERE WERE NO PATIENTS INJURED DURING ANY OF THE PROCEDURES. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECKI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304408 ↗
• MalfunctionDec 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT " DEFECTIVE PICC LINES. WE RETAINED ONLY THE TRACKING WIRE AND ITS COMPONENTS. THE EVENT DIRECTLY INVOLVED PATIENT CARE. EVENT OCCURRED DURING THE STERILE INSERTION PROCEDURE OF PERIPHERAL INSERTED CENTRAL CATHETER PLACEMENT. THE FAILURE POINT IS THE 3CG TRACKING WIRE GROMMET WITH POOR SEAL CLOSURE. THE YELLOW GROMMET IS NOT FULLY SEALED/TIGHT AROUND THE 3CG WIRE CAUSING AIR TO BE DRAWN INTO THE CATHETER DURING ASPIRATION FOR BLOOD CHECK AND OR DURING FLUSHING. IT ALSO IS SO LOOSE AND THE WIRE DOES NOT REMAIN SECURE AND MIGRATES. THE MIGRATION IS MINIMAL AND IS USUALLY LESS THAN A COUPLE MILLIMETERS THERE IS STILL THE POTENTIAL OF FURTHER MIGRATION. THERE WERE NO PATIENT INJURY DURING PROCEDURE. INTERVENTIONS INCLUDED ATTEMPTING TO REMEDY ANY USER ERROR SUCH AS CHECKING THAT TRACKING WIRE CONNECTION WAS FULLY SECURED ENSURING THIS WAS NOT THE POINT OF AIR INFILTRATION INTO CATHETER/SYRINGE. CHECKING THAT PROPER CONNECTION OF FLUSH SYRINGE WAS FULLY SECURED TO LUER CONNECTION TO ENSURE THIS WAS NOT THE FAILURE POINT. INTERVENTIONS THAT HELPED REMEDY THE ISSUE WERE PLUGGING GROMMET THAT 3CG WIRE THREADS THOUGH WITH THUMB TO HELP PROVIDE A BETTER SEAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302236 ↗
• MalfunctionDec 4, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HE CLEARED PLASTIC HUB WHICH THE INSERTION WIRE GOES THROUGH IS BOTH LEAKING AIR AND FLUID. WHEN HE DREW BACK TO CHECK FOR BLOOD FLOW, AIR GETS PULLED INTO SYRINGE. WHEN HE FLUSHED THE SALINE SQUIRTS OUT AROUND WIRE. IT IS MORE THAN JUST A BUBBLE OR TWO OF AIR. I OBSERVED BETWEEN 2-3 CC OF AIR DRAWN UP INTO FLUSH SYRINGE. IT WAS NOT DUE TO A LOOSE HUB. UNABLE TO QUANTIFY AMOUNT OF SALINE THAT LEAKS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258704 ↗
• MalfunctionNov 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY CUSTOMER THAT "WE HAVE BEEN HAVING SOME ISSUES WITH OUR 3FR PROVENA CATHETERS WHERE WE PLACE THE LINE WITHOUT ISSUE AND UPON OUR INITIAL CHECK FOR BLOOD RETURN AFTER REMOVING THE GUIDEWIRE, WE HAVE BLOOD RETURN HOWEVER BY THE TIME WE PLACE OUR DRESSING AND DO THE FINAL CHECK, WE NO LONGER HAVE BLOOD RETURN OR SHORTLY AFTER, WE ARE TOLD IT NO LONGER FLUSHES OR HAS BLOOD RETURN. IT HAS HAPPENED TWO TIMES IN THE PAST FEW WEEKS ON DIFFERENT TYPES OF PATIENTS." THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243295 ↗
• MalfunctionNov 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY CUSTOMER THAT "WE HAVE BEEN HAVING SOME ISSUES WITH OUR 3FR PROVENA CATHETERS WHERE WE PLACE THE LINE WITHOUT ISSUE AND UPON OUR INITIAL CHECK FOR BLOOD RETURN AFTER REMOVING THE GUIDEWIRE, WE HAVE BLOOD RETURN HOWEVER BY THE TIME WE PLACE OUR DRESSING AND DO THE FINAL CHECK, WE NO LONGER HAVE BLOOD RETURN OR SHORTLY AFTER, WE ARE TOLD IT NO LONGER FLUSHES OR HAS BLOOD RETURN. IT HAS HAPPENED TWO TIMES IN THE PAST FEW WEEKS ON DIFFERENT TYPES OF PATIENTS." THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242889 ↗
• MalfunctionNov 30, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY CUSTOMER ISSUE WITH OUR PROVENA CATHETER WHERE WE PLACED THE LINE WITHOUT ISSUE AND UPON OUR INITIAL CHECK FOR BLOOD RETURN AFTER REMOVING THE GUIDEWIRE, WE HAVE BLOOD RETURN HOWEVER BY THE TIME WE PLACE OUR DRESSING AND DO THE FINAL CHECK, WE NO LONGER HAVE BLOOD RETURN OR SHORTLY AFTER, WE ARE TOLD IT NO LONGER FLUSHES OR HAS BLOOD RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241785 ↗
• MalfunctionJul 14, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HE CLEARED PLASTIC HUB WHICH THE INSERTION WIRE GOES THROUGH IS BOTH LEAKING AIR AND FLUID. WHEN HE DREW BACK TO CHECK FOR BLOOD FLOW, AIR GETS PULLED INTO SYRINGE. WHEN HE FLUSHED TUBE SALINE SQUIRTS OUT AROUND WIRE. IT IS MORE THAN JUST A BUBBLE OR TWO OF AIR. I OBSERVED BETWEEN 2-3 CC OF AIR DRAWN UP INTO FLUSH SYRINGE. IT WAS NOT DUE TO A LOOSE HUB. UNABLE TO QUANTIFY AMOUNT OF SALINE THAT LEAKS OUT. ADDITIONAL INFO FROM CUSTOMER: 30-JUNE-2023 IT WAS NOT A BREAK NOTED. IT CAUSED DELAYS WITH INSERTION OF THE PICC LINE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324514 ↗
• MalfunctionJul 12, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HE CLEARED PLASTIC HUB WHICH THE INSERTION WIRE GOES THROUGH IS BOTH LEAKING AIR AND FLUID. WHEN HE DREW BACK TO CHECK FOR BLOOD FLOW, AIR GETS PULLED INTO SYRINGE. WHEN HE FLUSHED THE SALINE SQUIRTS OUT AROUND WIRE. IT IS MORE THAN JUST A BUBBLE OR TWO OF AIR. I OBSERVED BETWEEN 2-3 CC OF AIR DRAWN UP INTO FLUSH SYRINGE. IT WAS NOT DUE TO A LOOSE HUB. UNABLE TO QUANTIFY AMOUNT OF SALINE THAT LEAKS OUT. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313150 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT 1 PPICC PROVENA T-LOCK ASSEMBLY W/STYLET SUCKING AIR AT T-PIECE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17184346 ↗
• MalfunctionApr 26, 2023Defective Component; Defective Component

  CUSTOMER REPORTED TO BD VASCULAR ACCESS DEVICES SALES REPRESENTATIVE THAT THEY HAVE BEEN EXPERIENCING AIR WITHIN THE NEW SEPTUM OF THE PICC LINES THAT HOLDS THE WIRE THAT IS WITHIN OUR PICCS. IF THE NURSE PULLS BACK FOR BLOOD IT ALLOWS AIR AND THE SAME GOES FOR FLUSHING. ADDITIONAL INFO RECEIVED ON APRIL 24 2023 THERE IS SOME LEAKAGE AROUND THE GUIDE WIRE IN THE PICC LINE. IT ISN¿T TIGHT SEAL, SO WHEN THERE IS SOME RESISTANCE WHEN PUTTING IN THE PICC AND YOU ARE ATTEMPTING TO GET BLOOD RETURN THERE IS AIR COMING IN THE SYRINGE FROM AROUND THE WIRE AND WHEN ATTEMPTING TO FLUSH SALINE IS GOING OUT AROUND THE WIRE. THIS DOES NOT HAPPEN WHEN THE PICC LINE ADVANCED WITHOUT ANY DIFFICULTY. WHEN AIR IS BEING PULLED FROM AROUND THE WIRE WE THEN HAVE TO TAKE OFF THE SYRINGE TO TAKE THE AIR OUT TO KEEP FROM CAUSING AN AIR EMBOLI. THE WIRE ALSO GETS PUSHED OUT A LOT FASTER THAN IT USED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820626 ↗
• MalfunctionJan 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE PEDIATRIC PICC NURSE "ISSUES WITH INSERTING THE INTRODUCER. THE INTRODUCER WOULD BUCKLE AND THEN NOTICED THAT THERE WAS A BREAK IN BETWEEN THE WHITE AND GRAY PART. IT WAS ALMOST LIKE THE GRAY SHEATH WAS FALLING APART AS THEY INSERTED. NO HARM TO PATIENT BUT THIS REQUIRED THEM HAVING TO DROP A SECOND INTRODUCER ON THEIR STERILE FIELD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274315 ↗
• InjuryDec 7, 2022Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER "THEY HAD AN INCIDENT WHERE THE SHERLOCK 3CG STYLET WIRE BROKE OFF AND WAS FOUND ON CHEST X-RAY. SHE STATED THAT THIS HAPPENED TODAY, (B)(6)2022.".

  Patient problems: Foreign Body In Patient

  MAUDE report 15933586 ↗
• MalfunctionMar 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "MY CUSTOMER HAD A 3CG PICC PLACED ARTERIAL, TO MY KNOWLEDGE THE PATIENT WAS NOT HARMED AND THE EQUIPMENT PERFORMED AS IFU STATED." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED 2/22/2021: IT WAS REPORTED PROVIDER CANNULATED A 4.2MM RADIUS LEFT BRACHIAL VEIN. PROVIDER REPORTS ASSESSING VASCULAR STRUCTURES FOR PULSATILITY PRIOR TO CANNULATION. PROVIDER NOTED INCREASED BLOOD RETURN THROUGH STEEL NEEDLE BUT DENIED IT APPEARED ARTERIAL IN COLOR AND DENIED THAT IT WAS SPURTING OR PULSATILE. PROVIDER THEN PLACED US PROBE BACK ON THE VESSEL IN LONGITUDINAL ORIENTATION AND DID NOT SEE ANY PULSATILITY SO PROCEEDED WITH THE PROCEDURE. REPORTED GOOD SHERLOCK TRACING AND P WAVE AMPLIFICATION AND NEGATIVE DEFLECTION. ALSO NOTED GREEN HIGHLIGHTING OF P WAVE. CATHETER WAS REPORTEDLY FLUSHING AND DRAWING WITH EASE. NO FURTHER BLEEDING WAS NOTED. LINE WAS CLEARED USING 3CG. PT HAD MULTIPLE CXRS SUBSEQUENT TO PICC PLACEMENT WHERE RADIOLOGY READ LINE AS L BRACHIOCEPHALIC. ON 2/8 RADIOLOGIST RAISED CONCERN FOR POSSIBLE ARTERIAL PLACEMENT BASED ON TRAJECTORY OF PICC ON CXR. BLOOD GAS C/W ARTERIAL BLOOD, GAVE ARTERIAL WAVE FORM WHEN HOOKED UP TO CVP. VASCULAR SUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474645 ↗