Peripheral Catheter Insertion Kit F122088PTRecalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741140594), received between May 26, 2022 and Mar 15, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Defective Component1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER BROKEN ITEM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914890 ↗InjuryMar 7, 2024Break; Break
IT WAS REPORTED BY CUSTOMER ¿ON 2/13/24, AN EXPERIENCE POWER GLIDE MIDLINE NURSE WAS PLACING A 22 GAUGE 8 CM AST MIDLINE INTO A PATIENT'S RIGHT BASILIC VEIN. HE HAD THE NEEDLE INSIDE THE VEIN THE OF THE ANGLE OF THE DEVICE WAS LOW. THE NURSE WAS ABLE TO PUSH THE GUIDEWIRE IN WITH ONE SMOOTH MOTION. HE SLIDE THE CATHETER DOWN INTO THE PATIENT'S ARM WITH EASE. UPON PULLING THE NEEDLE/GUIDEWIRE OUT, THE CATHETER SHEARED APART ABOUT 5MMS BELOW THE HUB OF THE MIDLINE. THE REST OF THE CATHETER WAS BALLED UP ON THE GUIDEWIRE UNDER THE PATIENT'S SKIN. WE HAD TO DO A SMALL INCISION IN THE ARM SO WE COULD GRAB THE CATHETER WITH THE GUIDEWIRE TO ENSURE THAT IT WOULDN'T GET LOST IN THE PATIENT. THIS WAS WITNESSED BY A DOCTOR, BOTH OF US ARE TRAINED IN MIDLINES.¿ NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 18857882 ↗InjuryFeb 27, 2024
DESCRIPTION OF COMPLAINT: IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2024. AN EXPERIENCE POWER GLIDE MIDLINE NURSE WAS PLACING A 22 GAUGE 8 CM (LOT NUMBER REJN2430) AST MIDLINE INTO A PATIENT'S RIGHT BASILIC VEIN. HE HAD THE NEEDLE INSIDE THE VEIN THE OF THE ANGLE OF THE DEVICE WAS LOW. THE NURSE WAS ABLE TO PUSH THE GUIDEWIRE IN WITH ONE SMOOTH MOTION. HE SLIDE THE CATHETER DOWN INTO THE PATIENT'S ARM WITH EASE. UPON PULLING THE NEEDLE/GUIDEWIRE OUT, THE CATHETER SHEARED APART ABOUT 5MMS BELOW THE HUB OF THE MIDLINE. THE REST OF THE CATHETER WAS BALLED UP ON THE GUIDEWIRE UNDER THE PATIENT'S SKIN. WE HAD TO DO A SMALL INCISION IN THE ARM SO WE COULD GRAB THE CATHETER WITH THE GUIDEWIRE. TO ENSURE THAT IT WOULDN'T GET LOST IN THE PATIENT. THIS WAS WITNESSED BY TWO HEALTHCARE EMPLOYEES TRAINED IN MIDLINES. FOR LOT NUMBER. ITEM#F122088PT LOT#REJN2430. NO FOREIGN OBJECT OF CATHETER FRAGMENT NOTED WITH XRAY RESULT. HAVE PRODUCT AND PICTURES BUT THIS PROGRAM WILL NOT ACCEPT IN PDF FORMAT.
Patient problems: Device Embedded In Tissue or Plaque; Needle Stick/Puncture
MAUDE report 18809421 ↗InjuryJun 23, 2022Break; Break
IT WAS REPORTED VIA MEDWATCH "DURING MIDLINE INSERTION, 8CM OF MIDLINE TIP BROKE OFF IN THE RIGHT FOREARM WHEN GUIDEWIRE BECAME STUCK. PT REQUIRED SURGICAL INTERVENTION ON TO REMOVE. IT APPEARS WIRE WAS REMOVED SUCCESSFULLY WITHOUT LONG TERM HARM. IT IS UNCLEAR WHETHER THIS COULD BE RELATED TO TECHNIQUE BY NEW USER OR IS RELATED TO THE DEVICE DIRECTLY."
Patient problems: Foreign Body In Patient
MAUDE report 14793586 ↗InjuryMay 26, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED "PERFECTLY IN THE CENTER OF THE VESSEL. ADVANCED WIRE WITHOUT RESISTANCE AND ADVANCED CATHETER THREADED WITHOUT RESISTANCE AT THE VERY END SLIGHT RESISTANCE. WENT TO SAFETY THE NEEDLE AND RESISTANCE. COULDN¿T PULL BACK. HUB OF CATHETER BROKE FROM CATHETER. HAD TO USE FORCEPS TO GET NEEDLE AND GUIDE WIRE OUT. CATHETER STUCK IN PATIENT FOREARM."
Patient problems: Foreign Body In Patient
MAUDE report 14518128 ↗
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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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