Peripheral Catheter Insertion Kit F118087TRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741140457), received between Feb 23, 2021 and Sep 24, 2024 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- 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.
InjurySep 24, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD AN 18G 8CM POWERGLIDE IN FOR 9 DAYS. IT WAS LEAKING QUITE A BIT, SO THEY DECIDED TO REMOVE IT. ONCE THEY REMOVED IT, THEY SAW THAT THE HUB WAS SEPARATED FROM THE CATHETER. IR HAD TO REMOVE THE CATHETER FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20297992 ↗MalfunctionFeb 23, 2021Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED BY PLACER "THIS MIDLINE CAME APART ON ME TODAY WHEN I WAS ADVANCING THE CATHETER. IT WAS AN EASY STICK, DID IT JUST LIKE I ALWAYS DO, AND WHEN I WAS PULLING THE NEEDLE OUT THE WHOLE THING CAME APART." ADDITIONAL INFORMATION RECEIVED 02/02/2021: "I HAVE PLACED HUNDREDS OF POWERGLIDE MIDLINES. IN THIS INSTANCE, I FOUND A LARGE, EASY VESSEL TO ACCESS, ACCESSED THE VESSEL WITHOUT DIFFICULTY, THE GUIDEWIRE SLID FORWARD WITHOUT DIFFICULTY, THE WINGS/ CATHETER SLID IN OVER WIRE EASILY. WHEN I PULLED BACK TO ENABLE SAFETY MECHANISM, GUIDEWIRE AND HANDLE CAME OUT OF CORK/END OF CATHETER, BUT THE NEEDLE AND BLOOD COLLECTION/NEEDLE COVER REMAINED IN PLACE/CAME APART FROM THE REST OF THE MECHANISM.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11369308 ↗
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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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