Peripheral Catheter Insertion Kit F320108PTRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 20Ga, 10cm · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerGlide peripheral catheter insertion kit is a short-term IV catheter placed into a vein for access. The 43 reports mostly describe the device breaking apart during placement — the tip splitting, the catheter separating from its hub, or tubing pulling free — along with leaking at the hub and difficulty advancing the catheter, sometimes leaving a fragment in the patient. There are 13 injuries and no deaths. No recalls name this device.
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
- 42
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741140686), received between Apr 26, 2018 and Apr 27, 2026 — classified as 13 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Break” (12 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break12
- Fluid/Blood Leak12
- Improper or Incorrect Procedure or Method8
- Activation Problem5
- Leak/Splash2
- Material Deformation2
- Material Frayed2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Foreign Body In Patient12
- Insufficient Information4
- Hemorrhage/Blood Loss/Bleeding3
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Difficult to Remove
IT WAS REPORTED VIA MEDWATCH THAT WHILE I WAS PLACING A POWER GLIDE FOR PATIENT IN R [RIGHT] BASILIC. I LOCATED VESSEL AND WAS ABLE TO GET BLOOD RETURN. I ADVANCED WIRE WITHOUT ANY ISSUES OR RESISTANCE. I THEN WENT TO ADVANCE CATHETER. THE DEVICE SPLIT APART AT THE TIP AND THE CATHETER WOULD NOT ADVANCE. THE PATIENT COMPLAINED OF PAIN. I ATTEMPTED TO PULL DEVICE BACK AND AT THE INSERTION SITE, THE DEVICE WAS NOT COMPLETELY COMING OUT. THE SKIN WAS BEING PULLED/TUGGED LIKE THE OBJECT WAS LARGER THAN THE INSERTION SITE. NO MAJOR HARM TO THE PATIENT. IR ASSISTED IN REMOVAL OF DEVICE FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000928 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT REPORTS LEAKING AT THE CATHETER HUB. NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965761 ↗MalfunctionApr 9, 2026
I WAS PLACING A POWER GLIDE FOR PATIENT IN R [RIGHT] BASILIC. I LOCATED VESSEL AND WAS ABLE TO GET BLOOD RETURN. I ADVANCED WIRE WITHOUT ANY ISSUES OR RESISTANCE. I THEN WENT TO ADVANCE CATHETER. THE DEVICE SPLIT APART AT THE TIP AND THE CATHETER WOULD NOT ADVANCE. THE PATIENT COMPLAINED OF PAIN. I ATTEMPTED TO PULL DEVICE BACK AND AT THE INSERTION SITE, THE DEVICE WAS NOT COMPLETELY COMING OUT. THE SKIN WAS BEING PULLED/TUGGED LIKE THE OBJECT WAS LARGER THAN THE INSERTION SITE.
Patient problems: Pain
MAUDE report 24829900 ↗MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED CATHETER SEPARATED FROM THE HUB. CATHETER WAS REMOVED AND A REGULAR PERIPHERAL IV CATHETER WAS USED. THE EVENT WAS NOT PART OF A CRITICAL OR URGENT MEDICAL SITUATION. THERE WAS NO HARM OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368672 ↗MalfunctionApr 21, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE BLOOD CONTAINMENT HUB BROKE OFF UPON REMOVAL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876780 ↗MalfunctionJan 6, 2025Material Deformation; Material Deformation
IT WAS REPORTED BY CUSTOMER THAT THE POWERGLIDE IS TURNING BACK ON ITSELF. AFTER THE CATHETER WAS INSERTED A REVIEW OF THE VESSEL WAS COMPLETED AND IT APPEARED THE CATHETER WAS TURNED AROUND ON ITSELF. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080859 ↗MalfunctionSep 11, 2024Break; Break
IT WAS REPORTED BY THE CLINICIAN THAT THE EXTENSION TUBING INCLUDED IN THE POWERGLIDE PRO INSERTION KIT BROKE AWAY AND SEPARATED FROM THE DISTAL FITTING WHERE THE NEEDLE FREE CONNECTOR ATTACHES AFTER INSERTION. NO REPORTED INJURIES TO THE PATIENT OR HEALTHCARE PROVIDE. THE MIDLINE WAS REMOVED. IT WAS A COMPLETE SEPARATION OF THE EXTENSION SET. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20197059 ↗MalfunctionAug 5, 2024
VESTIBULAR AUTOROTATION TEST (VAT) TO BEDSIDE FOR PERIPHERAL INTRAVENOUS LINE (PIV) PLACEMENT. PATIENT DIFFICULT IV ACCESS. DETERMINED POWERGLIDE MIDLINE TO BE PLACED. 20G 10CM POWERGLIDE MIDLINE PLACED TO LEFT CEPHALIC VEIN X 1 ATTEMPT. WHILE SECURING DEVICE WITH STATLOCK, POWERGLIDE FLUSHED WITH NORMAL SALINE (NS) AND SITE NOTED TO BE LEAKING NS. POWERGLIDE REMOVED IMMEDIATELY AND NEW 20G 10CM POWERGLIDE MIDLINE PLACED WITHOUT DIFFICULTY (FROM SAME LOT #). UPON INSPECTION OF DEFECTIVE POWERGLIDE MIDLINE, THE CATHETER TIP IS ALMOST FULLY DETACHED AT THE PROXIMAL PORTION OF THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905702 ↗InjuryJun 24, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED LENGTH OF MIDLINE CATHETER SHEARED OFF DURING INSERTION, REQUIRING OPERATING ROOM TO REMOVE FORM VEIN. HERE IS ONE FOR A BROKEN MIDLINE THAT REQUIRED SURGERY TO REMOVE THE PIECE THAT BROKE OFF. ADDITIONAL INFORMATION 06/05/2024: IT WAS REPORTED THE ADVERSE EVENT THAT THE PATIENT EXPERIENCED WAS HAVING TO GO TO THE OPERATING ROOM TO HAVE THE RETAINED LENGTH OF CATHETER REMOVED FROM HER ARM. THIS WAS A SURGERY THAT SHE OTHERWISE WOULD NOT HAVE NEEDED. SHE TOLERATED THE SURGERY WELL AND I DO NOT KNOW OF ANY OTHER COMPLICATIONS. THE IV THERAPY NURSE WAS ATTEMPTING TO PLACE THE MIDLINE WHEN THEY ENCOUNTERED RESISTANCE. THEY TRIED TO REMOVE THE CATHETER FROM THE PATIENT BUT WHEN THEY PULLED IT OUT, THEY NOTICED THAT A PART OF THE CATHETER WAS STILL IN THE PATIENT. THE MD WAS NOTIFIED AND THE PATIENT HAD AN X-RAY DONE THAT SHOWED THE PIECE OF THE CATHETER IN THE PATIENT¿S VEIN. SURGERY WAS EMERGENTLY ORDERED AND THE PATIENT WAS IN THE OPERATING ROOM SOON AFTER THAT. THE CATHETER PIECE WASN¿T IN HER ARM FOR MORE THAN A COUPLE HOURS AT MOST. ADDITIONAL INFORMATION PROVIDED 06/19/2024: PATIENT WAS ADMITTED STARTING (B)(6) 2024.
Patient problems: Foreign Body In Patient
MAUDE report 19595085 ↗InjuryJun 19, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT WHEN PLACING A POWER GLIDE 10CM 20G CATHETER, NOTED THAT ONLY 5.75CM OF CATHETER CAME OUT AFTER FAILED INSERTION. 4.25CM LIKELY REMAINED IN LUA BRACHIAL VEIN. NOTIFIED THE DOCTOR WHO CONTACTED VASCULAR AND ADMITTED THE PATIENT TO SURGERY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 19568538 ↗InjuryMay 1, 2024Material Frayed; Material Frayed
IT WAS REPORTED BY CUSTOMER HAD AN INCIDENT WITH A LINE TODAY LINE WOULDN¿T ADVANCE AND THEN WHEN PULLED OUT HAD RESISTANCE. DID X-RAY AND LOOKS LIKE A PIECE OF THE LINE OR GUIDE WIRE BROKE OFF IN PATIENT'S ARM. INSERTED BY A NURSE.
Patient problems: Foreign Body In Patient
MAUDE report 19225340 ↗MalfunctionApr 12, 2024Material Deformation; Material Deformation
IT WAS REPORTED BY CUSTOMER THAT THE RN INSERTED THE POWERGLIDE MIDLINE. INITIALLY HAD A GOOD BLOOD RETURN BUT UNABLE TO FLUSH. CONFIRMED TIP PLACEMENT USING ULTRASOUND MACHINE. THE RN STATED THAT SHE WAS ABLE TO VISUALIZE THE TIP INSIDE THE VESSEL BUT UNABLE TO FLUSH THE CATHETER. MIDLINE CATHETER WAS REMOVED. SHE ASSESSED THE CATHETER AND NOTICED A KINKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100140 ↗InjuryApr 5, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED, "MIDLINE CATHETER BROKE OFF IN PATIENT VEIN DURING INSERTION ATTEMPT. NURSE ATTEMPTING TO INSERT A 20G 10CM MIDLINE IN THE PATIENTS RIGHT CEPHALIC. ON ULTRASOUND, THE TIP OF THE NEEDLE STARTED TO HIT THE BOTTOM OF THE VEIN WHILE ADVANCING. THE CATHETER WAS NOT COMPLETELY ADVANCED TO THE HUB OF THE NEEDLE. NURSE PULLED THE NEEDLE BACK SLIGHTLY SO THE NEEDLE WAS IN THE CENTER OF THE VEIN. ABOUT HALF OF THE NEEDLE WAS IN. NURSE ADVANCED THE GUIDEWIRE WITHOUT ISSUE OR RESISTANCE. NURSE WENT TO ADVANCE THE CATHETER AND AS THEY WERE ADVANCING THERE STARTED TO BE RESISTANCE AND NURSE COULD SEE THE CATHETER START CURLING UNDER THE SKIN. NURSE STOPPED AND WITHDREW THE CATHETER BACK. IT STARTED BLEEDING FROM THE INSERTION SITE WITH THE NEEDLE AND GUIDEWIRE STILL IN. NURSE PULLED OUT GUIDEWIRE AND THEN THE NEEDLE AND NOTICED PART OF THE CATHETER WAS MISSING. NURSE HELD PRESSURE, KEPT TOURNIQUET ON ARM UNTIL PHYSICIAN COULD ASSESS SITUATION. LOOKED WITH ULTRASOUND AND COULD SEE THE PIECE OF CATHETER STUCK IN THE PATIENTS VEIN".
Patient problems: Foreign Body In Patient
MAUDE report 19056175 ↗MalfunctionApr 1, 2024Activation Problem; Activation Problem
IT WAS REPORTED THAT POWERGLIDE SAFETY CYLINDER NOT ACTIVATED, STAYED WITHIN POWERGLIDE "HOUSE". SHARP BEVEL NOT SAFTIED AFTER CATHETER THREADED INTO PATIENT. NO HARM TO PATIENT OR CLINICIAN, CATHETER SUCCESSFULLY INSERTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014516 ↗MalfunctionMar 6, 2024Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER THE LINE WAS INSERTED AROUND 1447 WITHOUT ISSUE AND WAS FUNCTIONING WELL WHEN IV TEAM MEMBER LEFT THE PATIENT. AT APPROXIMATELY 1730 NURSING TEAM NOTED BLEEDING AT SITE OF IV INSERTION OF SKIN. IV FLUSHED AND + BLOOD RETURN. COAG PATCH APPLIED OVER INSERTION SITE AND TEGADERM APPLIED. AT CHANGE OF SHIFT PATIENT WITH OOZING DILUTED BLOODY FLUID. INFUSION WAS STOPPED. SITE UNDRESSED AND STAFF FOUND FLUID BUBBLING OUT OF ACTUAL IV INSERTION SITE CATHETER WHERE ANGIO CATHETER CONNECTS INTO THE PLASTIC HUB. ADDITIONAL INFORMATION RECEIVED 12 FEBRUARY 2024: THERE WAS NO HARM TO THE PATIENT. PATIENT WAS A DIFFICULT ACCESS AND PIV WAS PLACED TO REPLACE THE MIDLINE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18846976 ↗InjuryFeb 23, 2024Break; Break
IT WAS REPORTED, "PART OF CATHETER WAS MISSING WHEN IT WAS RETRACTED." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 18767804 ↗MalfunctionSep 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED A RETURNED SAMPLE IS THE CATHETER FROM A 20GA POWERGLIDE PRO WITH UNKNOWN DEFECT. NO OTHER INFORMATION WAS PROVIDED. IT WAS FOUND DURING AN INVESTIGATION ON (B)(6) 2023 THAT AN IRREGULARLY SHAPED SPLIT WAS FOUND IN THE CATHETER TUBING.
Patient problems: Insufficient Information
MAUDE report 17839582 ↗MalfunctionSep 28, 2023Break; Break
IT WAS REPORTED BY CUSTOMER THAT CATHETER SHEARED OFF NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17830744 ↗MalfunctionSep 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THEY PLACED POWERGLIDE INTO VEIN WHEN PREPARING TO SECURE DEVICE TO SKIN NOTICED BLEEDING FROM SITE ATTEMPTED TO FLUSH MIDLINE WITH NORMAL SALINE AND NOTICED THE SALINE WAS LEAKING FROM THE SITE AS WELL. INSPECTED THE CATHETER AND NOTICED LEAKING FROM THE CATHETER-HUB JUNCTION. THE DEVICE WAS REMOVED FROM PATIENT. PATIENT WAS LEFT WITHOUT IV ACCESS. AND REQUIRED ANOTHER STICK. ADDITIONAL INFORMATION RECEIVED ON 02-SEP-2023: WHEN ATTEMPTING TO SECURE THE CATHETER WITH THE STATLOCK THE SITE WAS LEAKING BLOOD, WHEN THE HUB WAS LIFTED SLIGHTLY IT BECAME WORSE, PLACER WAS INSTRUCTED TO REMOVE THE DEVICE. WHEN REMOVED AND FLUSHED THERE WAS A SMALL HOLE IN THE DEVICE WHERE THE CATHETER WHEN FLUSHING. ANOTHER DEVICE HAD TO BE INSERTED AND REQUIRED AN ADDITIONAL STICK FOR THE PATIENT THIS WAS NOT AN URGENT SITUATION. THE PRODUCT WAS DISCARDED BECAUSE OF CONTAMINATION WITH BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17764476 ↗MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT CATHETER HAD HOLES WHERE THE CATHETER AND THE HUB MEET. THEY HAD TO PULL THE CATHETER AND PLACE ANOTHER ONE. IT WAS STATED IT WAS THE HOLE WAS DISCOVERED IMMEDIATELY AFTER PLACING. NO PRIMING COULD BE PERFORMED ON THIS DEVICE. CATHETER BLED AND LEAKED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17313001 ↗MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD TWO SEPARATE CATHETERS THAT HAD HOLES WHERE THE CATHETER AND THE HUB MEET. THEY HAD TO PULL THE CATHETER AND PLACE ANOTHER ONE. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Insufficient Information
MAUDE report 17234642 ↗MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD TWO SEPARATE CATHETERS THAT HAD HOLES WHERE THE CATHETER AND THE HUB MEET. THEY HAD TO PULL THE CATHETER AND PLACE ANOTHER ONE. ADDITIONAL INFO RECEIVED ON 23-JUNE-23 THE INITIAL DEFECT WAS FOUND ABOUT AN HOUR AFTER PLACEMENT, CATHETER BLED AND LEAKED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information
MAUDE report 17231350 ↗MalfunctionJun 20, 2023Activation Problem; Activation Problem
IT WAS REPORTED THAT DEVICE DID NOT PROPERLY SAFETY AND NEEDLE WAS EXPOSED. PATIENT AND CLINICIAN WERE NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163097 ↗MalfunctionJun 8, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER "I ADVANCED THE GUIDE WIRE WITH NO ISSUES. ONCE I ADVANCED THE WINGS THERE WAS A POP SENSATION AND THE WINGS ADVANCED. UPON REMOVAL OF POWERGLIDE BASE, I NOTED NO NEEDLE SAFETY SHIELD ON THE END OF NEEDLE. ONLY GUIDE WIRE AND NEEDLE EXPOSED. UPON OPENING BASE TO ENSURE PARTS WERE LEFT IN PATIENT, NOTED SAFETY AT BASE OF NEEDLE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17087626 ↗MalfunctionMar 3, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT "WHILE INSERTING POWERGLIDE AND ENGAGING THE SAFETY MECHANISM, THE SMALL NEEDLE COVER DID NOT CAP THE NEEDLE. INSTEAD THE NEEDLE CAME OUT UNCOVERED AND THE SMALL CLEAR HOUSING STAYED ATTACHED TO THE PINK WINGS OF THE PLUG IN THE END OF THE POWERGLIDE HUB".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479242 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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