Peripheral Catheter Insertion Kit F218081Recalls & reported problems
Bard Access Systems, Inc. · DOT PFlex, 18G 8cm Full w/o GIVa · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741110658), received between Jun 27, 2017 and May 21, 2022 — classified as 3 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
- Defective Component1
- Partial Blockage1
Patient problems
- No Known Impact Or Consequence To Patient2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2022Defective Component; Defective Component
IT WAS REPORTED "ATTEMPTING TO INSERT POWER GLIDE AND PATIENT COMPLAINING OF UNUSUAL PAIN UPON INSERTION. UNABLE TO ADVANCE NEEDLE DUE TO FEELING RESISTANCE UPON INSERTION. REMOVED DEVICE AND UPON FURTHER INSPECTION THE CATHETER APPEARED TO BE CUT SHORT AND NOT TAPERED ONTO NEEDLE." (B)(6) 2022 - THE TIP OF THE CATHETER OF THE RETURNED DEVICE APPEARED DEFORMED.
Patient problems: Pain
MAUDE report 14465070 ↗MalfunctionAug 30, 2017Break
PER SALES REP, THE FACILITY REPORTED THAT THE TUBING SEEMED TO BECOME WEAK AND IT BROKE OFF BEFORE THE CONNECTED SITE OF THE MIDLINE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6830797 ↗MalfunctionJun 27, 2017Partial Blockage
IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT DURING INJECTION FOR CT THE POWERGLIDE CATHETER WAS NOTED TO BE BLOCKED BETWEEN THE LUMEN AND THE CATHETER. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6672341 ↗
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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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