Peripheral Catheter Insertion Kit F120088PTRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 20Ga, 8cm · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741140570), received between Jun 1, 2022 and Aug 12, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 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 Component2
- Fluid/Blood Leak2
- Improper or Incorrect Procedure or Method2
- Activation Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING A BEDSIDE POWERGLIDE PRO INSERTION, THE CUSTOMER ADVANCED THE GUIDEWIRE, STATED SHE FELT NO RESISTANCE, AND THREADED THE CATHETER INTO THE SKIN. SHE WENT TO RETRACT THE NEEDLE AND DEVICE, SHE SAID IT FELT STUCK. SHE TRIED TO REMOVE THE NEEDLE AND DEVICE FROM THE CATHETER ONCE MORE AND SAID IT WAS STILL STUCK. SHE WENT TO REMOVE THE ENTIRE DEVICE AND CATHETER FROM THE SKIN. WHEN SHE ATTEMPTED TO DO SO, SHE SAID IT ALSO FELT STUCK. SHE GENTLY TRIED AGAIN AND WAS UNABLE TO REMOVE IT. THERE WAS AN OBSERVED TEAR IN THE CATHETER THAT WAS IMMEDIATELY OUTSIDE OF THE INSERTION SITE. THE ATTENDING WAS CALLED TO COME AND ASSESS THE SITUATION. THE ATTENDING CAME DOWN AND WAS ABLE TO RETRIEVE THE CATHETER AND DEVICE USING A SUTURE REMOVAL KIT. HE MADE A SMALL SKIN NICK AT THE INSERTION SITE AND SLOWLY PULLED OUT THE CATHETER WITH TWEEZERS. THE TIP OF THE WIRE AND THE TIP OF THE CATHETER WERE BOTH INSPECTED AND BOTH REMAINED INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790314 ↗MalfunctionJul 30, 2025Defective Component; Activation Problem; Defective Component; Activation Problem
IT WAS REPORTED THAT DURING THE PULL BACK PORTION, AFTER THE INSERTION, THE WHOLE PIECE COMES WITH THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667102 ↗MalfunctionMar 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT WHEN THE DEVICE WAS PLACED INTO THE PATIENT AND REMOVED THE DEVICE WAS IN A KNOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21527941 ↗MalfunctionAug 18, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED "DURING A TRAINING WITH POWERGLIDE PRO, NURSE THREADED GUIDEWIRE WITHOUT RESISTANCE AND THEN TRIED TO THREAD CATHETER OFF AND FELT RESISTANCE ABOUT HALFWAY AND STOPPED. NURSE THEN PULLED BACK ON WINGS. THREADED CATHETER AGAIN WITH NOT A LOT OF RESISTANCE JUST PATIENT PULLING ARM BACK. THEN SHE WAS INSTRUCTED TO SAFETY CATHETER, WHEN SAFETY WAS ACTIVATED GUIDEWIRE APPEARED NOT TO BE IN PLACE. CATHETER REMOVED FROM PATIENT. NOT SIGN OF TRAUMA, HOWEVER GUIDEWIRE INSIDE OF CATHETER. GUIDEWIRE WAS NOT BROKEN IN PATIENT ARM, ALL OF THE GUIDEWIRE IS INSIDE ON CATHETER. WE ARE HAVING THEM TAKE A X-RAY OF THE PATIENTS ARM AND CHEST JUST TO DOUBLE CHECK THAT NONE OF THE WIRE IS STILL INSIDE THE PATIENT. X-RAY FOR RIGHT ARM AND CHEST ORDERED BY CLINICIAN." (B)(6) 2022 - THE RETURNED SAMPLE EXHIBITED A SPLIT AND MULTIPLE BENDS.
Patient problems: Pain
MAUDE report 15255337 ↗MalfunctionJun 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "NURSE SHARED THAT THE POWERGLIDE INSERTED WELL IN THE VEIN AND THE WIRE DEPLOYED SUCCESSFULLY HOWEVER DURING THE PART OF ADVANCING THE CATHETER RESISTANCE WAS MET. AFTER RESISTANCE WAS MET THE NURSE REMOVED THE ENTIRE SET WITH EVERYTHING INTACT SUCCESSFULLY AND OBSERVED THE CATHETER GOING THROUGH THE NEEDLE AND THE WIRE BEING BUNDLED UP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14650575 ↗MalfunctionJun 1, 2022Improper or Incorrect Procedure or Method; Defective Component; Improper or Incorrect Procedure or Method; Defective Component
IT WAS REPORTED "NURSE TELLING ME THERE IS NO RE- RECANULATE WHEN SHE MET RESISTANT SHE REMOVED IMMEDIATELY, SO THERE WAS NO OPPORTUNITY FOR THAT TO HAPPEN. THIS IS THE 28 CM DEVICE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14568495 ↗
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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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