Peripheral Catheter Insertion Kit F318087TRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741140501), received between May 31, 2019 and Sep 19, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Material Frayed2
- Contamination /Decontamination Problem1
- Material Separation1
- Unraveled Material1
- Unsealed Device Packaging1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2024Break; Material Frayed; Break; Material Frayed
IT WAS REPORTED BY MEDWATCH THAT ON INSERTION GUIDEWIRE GOT STUCK IN EXTREMITY. GUIDEWIRE THEN SUCCESSFULLY REMOVED, A FRAGMENT OF THE ACTUAL MIDLINE BROKE OFF IN PATIENT EXTREMITY CONFIRMED BY ULTRASOUND AND HAD TO BE SURGICALLY REMOVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20258084 ↗InjuryAug 23, 2024Break; Material Frayed; Break; Material Frayed
IT WAS REPORTED SUCCESSFULLY INSERTED THE VESSEL WITH 18-GAUGE NEEDLE AND GUIDEWIRE WAS DEPLOYED. AFTER GUIDEWIRE WAS DEPLOYED AND IN VEIN WITH ULTRASOUND CONFIRMED THE POWERGLIDE CATHETER WAS INSERTED INTO THE VESSEL. WHEN TRYING TO RETRACT THE GUIDEWIRE OUT IT SEEMED DIFFICULT TO RETRACT. WHEN I WAS ABLE TO PULL THE POWERGLIDE OUT I HAD NOTICED THE GUIDEWIRE WAS CURLED. AFTER THE ATTEMPT TO PLACE POWERGLIDE WITH ULTRASOUND THE PATIENT UPPER ARM WAS SCANNED AND WE NOTICED THAT THERE WAS POSSIBLY A PIECE OF THE POWERGLIDE CATHETER LEFT INSIDE THE PATIENT ARM. DURING THE ENTIRE PROCESS THE PATIENT WAS ASKED MULTIPLE TIMES IF SHE WAS IN ANY PAIN OR DISCOMFORT AND PATIENT STATED SHE WAS NOT IN ANY PAIN OR DISCOMFORT. I DID EXPLAIN THE ENTIRE SITUATION TO THE PATIENT AND TOLD HER WHAT HAD HAPPENED. SHE WAS EXTREMELY CALM AND STATED TO BE IN NO PAIN. I NOTIFIED HER THE NEXT STEP I WOULD TAKE WOULD BE CONTACTING HER MD TO EXPLAIN WHAT HAPPENED AND TO GET CONFIRMATION. ADDITIONAL INFORMATION ON 08/06/2024: PATIENT HAD SURGERY TO REMOVE THE PIECE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20055074 ↗MalfunctionOct 25, 2023Unsealed Device Packaging; Contamination /Decontamination Problem; Unsealed Device Packaging; Contamination /Decontamination Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY OPENED THE PRODUCT, IT WAS EVIDENT THE CONTENT INSIDE WAS NOT STERILE. ADDITIONAL INFORMATION PROVIDED 16 OCT 2023 : THIS PRODUCT WAS OPENED AND VISIBLE SOILED. THIS WAS NOT USED ON ANY PATIENT. NO LIFE THREATENING SITUATION, OR DELAYED MEDICATION OR CARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18006021 ↗MalfunctionMay 31, 2019Material Separation; Unraveled Material
IT WAS REPORTED THAT THE POWERGLIDE WAS BEING PLACED IN THE UPPER ARM WHEN THE WIRE PULLED APART AND UNRAVELED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8658936 ↗
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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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