Peripheral Catheter Insertion Kit F122087TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 22Ga, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741140495), received between Apr 13, 2018 and Jul 1, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Material Fragmentation1
- Material Frayed1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2020Material Frayed; Material Frayed
IT WAS REPORTED "I WAS PLACING A POWERGLIDE PRO ON FRIDAY. I ADVANCED THE GUIDEWIRE AND THEN THE CATHETER. HOWEVER THE SAFETY DID NOT FULLY ENGAGE AND THEN THERE WAS RESISTANCE WHEN ATTEMPTING TO REMOVE THE NEEDLE AND GUIDEWIRE. I INCREASED BY PRESSURE AND FELT A SUDDEN POP AND RELEASE OF PRESSURE. AT THAT POINT THE GUIDEWIRE DID NOT SEEM TO BE THE CORRECT LENGTH, I ATTEMPTED TO ASPIRATE BLOOD BUT THAT WAS NOT SUCCESSFUL. DECISION WAS MADE TO REMOVE THE CATHETER. ONCE REMOVED IT APPEARED ON US THAT PART OF THE CATHETER OR GUIDEWIRE REMAINED IN THE PATIENT. ARM AND CHEST X-RAYS OBTAINED STAT, NO CATHETER FRAGMENT IDENTIFIED. FURTHER INVESTIGATION REVEALED GUIDEWIRE PIECE RETAINED IN THE CATHETER." ADDITIONAL INFORMATION RCVD 06/11/2020 - MIDLINE PLACED UNDER STERILE CONDITIONS WITH ULTRASOUND. VESSEL PUNCTURED AND NEEDLE ADVANCED TO BE SEATED IN THE VESSEL. GUIDEWIRE ADVANCED WITHIN THE VESSEL AND FULLY ENGAGED. CATHETER SLID OF THE NEEDLE AND OVER THE GUIDEWIRE WITHOUT ISSUE. AS I ATTEMPTED TO PULL THE NEEDLE AND GUIDEWIRE ALL THE WAY OUT OF THE CATHETER RESISTANCE WAS MET. AN ASSISTANT APPLIED STERILE GLOVES TO ASSIST, IN AN EFFORT TO SAVE THE LINE ANOTHER ATTEMPT WAS MADE TO REMO
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10217464 ↗MalfunctionApr 13, 2018Break; Material Fragmentation
IT WAS REPORTED THAT DURING INSERTION OF CATHETER, THE CATHETER BROKE WITH THE WIRE REMAINING THREADED THROUGH THE LUMEN. IT WAS STATED THAT THE CLINICIAN WAS UNABLE TO FULLY WITHDRAW WIRE AND BROKEN CATHETER. SURGEON WAS CONSULTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7429973 ↗
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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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