PowerPICC Provena S1275108FD5Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant
All models of PowerPICC Provena (116)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPICC catheter placement kit has 129 adverse event reports on record, with no deaths and 5 injuries. The reports mostly describe parts that fail, such as connections that leak or come apart, and some mention needles detaching or wires kinking. Most say no clinical signs were reported. There are no recalls naming this device. The last 12 months show 2 reports, compared with 10 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 129
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00801741155161), received between Jul 24, 2018 and Jul 10, 2026 — classified as 5 injuries, 124 malfunctions.
The most frequently reported specific device problem is “Defective Component” (59 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.
Reports received per month
Most reported problems
Device problems
- Defective Component59
- Fluid/Blood Leak14
- Material Deformation7
- Detachment of Device or Device Component5
- Break4
- Material Frayed4
- Physical Resistance/Sticking3
- Activation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions103
- Insufficient Information12
- No Known Impact Or Consequence To Patient3
- Device Embedded In Tissue or Plaque2
- Foreign Body In Patient2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE, THE 25GA HYPODERMIC NEEDLE USED TO ADMINISTER LIDOCAINE BECAME DETACHED FROM THE HUB WHILE THE NURSE WAS ADMINISTERING THE MEDICATION. THE NURSE WAS ABLE TO SAFELY REMOVE THE NEEDLE FROM THE PATIENT WITHOUT COMPLICATION. NO INJURIES TO PATIENT OR CAREGIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782751 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PURPLE HUB DISCONNECTED FROM TUBING WHILE PATIENT WAS BEING REPOSITIONED. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NOT A SIGNIFICANT DELAY IN TREATMENT AS THE TEAM WAS ABLE TO REPLACE QUICKLY. NO PATIENT INJURY WAS CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25151541 ↗MalfunctionApr 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN, WHILE PLACING BEDSIDE PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] FOR PATIENT. UNFORTUNATELY, THE EXTENSION CONNECTION WAS LEAKING. WE WERE ABLE TO SUCCESSFULLY PLACE THE PICC BY REPLACING THE EXTENSION. NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21915633 ↗MalfunctionApr 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT UPON SUCCESSFUL PROCEDURE COMPLETION, A KINK IS NOTED AT THE DISTAL END OF THE STYLETTE WIRE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21892813 ↗MalfunctionApr 23, 2025Defective Component; Defective Component
IT WAS REPORTED THAT NORMAL SALINE LEAKS BRISKLY AROUND STYLETTE WIRE THROUGH THE T-LOCK STOPPER WHILE PREPARING THE CATHETER FOR INSERTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21892810 ↗MalfunctionMar 6, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY MEDSUN SAFETY ON SECURELOC INTRODUCER NEEDLE DID NOT ENGAGE AFTER ACCESSING THE VEIN DURING PICC INSERTION. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21542863 ↗MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS LEAKING AT LUMENS JUNCTION RESULTING IN PULLING OF PICC AND REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21505453 ↗MalfunctionFeb 25, 2025Activation Problem; Activation Problem
IT WAS REPORTED VIA MEDWATCH "WHILE INSERTING A PICC, THE SAFETY COMPONENT OF THE NEEDLE PROVIDED IN THE KIT MALFUNCTIONED. THE NEEDLE HAS A GREEN PORTION THAT IS MOVED TO THE TIP OF THE NEEDLE (AFTER IT IS USED) TO COVER THE POINT AND AVOID NEEDLE STICK INJURY. USUALLY THE GREEN PORTION LOCKS ON THE NEEDLE TIP. THIS TIME, THE GREEN PORTION CAME RIGHT OFF THE USED NEEDLE, THUS EXPOSING THE DIRTY TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458757 ↗MalfunctionDec 31, 2024Material Deformation; Material Deformation
IT WAS REPORTED VIA MEDWATCH THAT THE USER WAS UNABLE TO ADVANCE INTRODUCER INTO PATIENT'S BASILIC VEIN. THE INTRODUCER SHEATH FOLDED BACK, AND TIP CRUMPLED UPON INSPECTION. NEW INTRODUCER USED AND THE INSERTED WAS COMPLETED WITHOUT ANY DIFFICULTY. NO HARM TO PATIENT WAS REPORTED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047186 ↗MalfunctionDec 3, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT WHILE FLUSHING PICC THE RUBBER STOPPER POPPED OUT. DEFECTIVE AND NOT ABLE TO BE PUSHED BACK INTO SPACE WHERE RUBBER STOPPER WAS. PICC SUCCESSFULLY PLACED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20835370 ↗MalfunctionNov 26, 2024Defective Component; Defective Component
IT WAS REPORTED VIA MEDSUN, FELLOW VAT INSERTING PICC LINE AND WHILE FLUSHING PICC THE RUBBER STOPPER POPPED OUT. DEFECTIVE AND NOT ABLE TO BE PUSHED BACK INTO SPACE WHERE RUBBER STOPPER WAS. PICC SUCCESSFULLY PLACED. NO PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20783697 ↗MalfunctionNov 26, 2024Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED VIA MEDSUN, DURING BEDSIDE PLACEMENT OF THE POWERPICC PROVENA CATHETER, THE RUBBER LIKE STOPPER BECAME DISLODGED LEAKING FLUID. PICC SUCCESSFULLY PLACED. NO SERIOUS INJURY OR IMPACT TO PATIENT OR HEALTHCARE PROFESSIONAL. PICC WAS REMOVED AND REPLACED WITH A NEW ONE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20781999 ↗MalfunctionSep 27, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER 2 EVENTS WHERE THE PLASTIC CAP HAS DISLODGED DURING PICC PLACEMENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO EVENTS. THIS REPORT ADDRESSES BOTH EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20318039 ↗MalfunctionJun 24, 2024
TWO INSTANCES OF PICC LINES NOT PRODUCING WITH BLOOD RETURN AFTER TROUBLESHOOTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593483 ↗MalfunctionMar 23, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER VIA MEDWATCH THAT DURING PICC PLACEMENT, BD POWERPICC PROVENA CATHETER LEAKING AT RUBBER-LIKE T PIECE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18965504 ↗MalfunctionFeb 28, 2024
DURING PICC PLACEMENT, BD POWERPICC PROVENA CATHETER LEAKING AT RUBBER-LIKE T PIECE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18796461 ↗MalfunctionJan 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED, ¿I FOUND A HAIR IN A 5FR PICC KIT STUCK IN A BLADE. I CAN ASSURE YOU THAT IT WASN¿T OUR HAIR.¿ NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED 01/12/2024: IT WAS REPORTED, ¿I HAD TO SWITCH OUT THE KIT. WE FOUND THE HAIR IN THE MIDDLE OF THE PROCEDURE. NO PATIENT IMPACT.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603392 ↗MalfunctionJan 22, 2024Contamination /Decontamination Problem; No Apparent Adverse Event; Contamination /Decontamination Problem; No Apparent Adverse Event
IT WAS REPORTED CLINICIAN FINDING WHAT APPEAR TO BE 2 MAGNETS LOOSE IN PICC INSERTION TRAY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18557310 ↗MalfunctionJan 8, 2024Defective Component; Defective Component
IT WAS REPORTED VIA MEDWATCH "DOUBLE LUMEN PICC PLACED WITH LEAKAGE NOTED A T PIECE CONNECTOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18471189 ↗MalfunctionDec 21, 2023
DOUBLE LUMEN PICC PLACED WITH LEAKAGE NOTED A T PIECE CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18371163 ↗MalfunctionDec 7, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE FROM THE TPORT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18283495 ↗MalfunctionDec 6, 2023Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER THAT LEAKAGE ISSUE WITH REGARDS TO THE T-LOCK. USER IMPACT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18274984 ↗MalfunctionDec 4, 2023Defective Component; Defective Component
IT WAS REPORTED VIA MEDWATCH "LEAKAGE NOTED AT T PIECE RUBBER-LIKE CONNECTOR WITH PRIMING. INTENDED PROCEDURE WAS PICC PLACEMENT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18257525 ↗MalfunctionNov 14, 2023
LEAKAGE NOTED AT T PIECE RUBBER-LIKE CONNECTOR WITH PRIMING.
Patient problems: Insufficient Information
MAUDE report 18130803 ↗MalfunctionOct 23, 2023
NURSE WAS PLACING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE UNABLE TO USE FILTER NEEDLE AS IT WAS FUSED SHUT, DIRECTLY OUT OF THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17985057 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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