Peripheral Catheter Insertion Kit F318088TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 18Ga, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741140709), received between Dec 23, 2021 and Dec 23, 2021 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2021Break; Defective Component; Break; Defective Component
IT WAS REPORTED "NURSE RETRACTED GUIDEWIRE AND WENT TO SHEATH THE NEEDLE NOTICED THAT THE END WAS MISSING (INITIALLY THOUGHT THE GUIDEWIRE SNAPPED) RUSHED THE PATIENT TO ER FOR X-RAY - X-RAY REVEALED NOTHING." ADDITIONAL INFORMATION RECEIVED 12/20/2021: "NO FOREIGN BODY WAS IDENTIFIED ON X-RAY. THE LENGTH OF GUIDEWIRE APPEARS TO BE COILED IN THE HANDLE OF THE INSERTION DEVICE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13078847 ↗
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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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