Peripheral Catheter Insertion Kit F118088PTRecalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741140556), received between Mar 29, 2019 and Mar 20, 2025 — classified as 1 injury, 5 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
- Activation Problem1
- Contamination /Decontamination Problem1
- Malposition of Device1
- Material Discolored1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2025Material Frayed; Material Frayed
IT WAS REPORTED WHILE TRYING TO INSERT A 18G 10CM MIDLINE INTO THE PATIENT, THE GUIDEWIRE BECAME STUCK. UPON REMOVING THE NEEDLE/GUIDEWIRE THE GUIDE WIRE RIPPED AND PULLED HALF MOSTLY OUT. UPON REMOVING THE CATHETER, THE REST OF THE GUIDEWIRE APPEARED AT THE END OF THE CATHETER TIP WITH BENDS/COILS. PATIENT HAD TO BE STUCK AGAIN. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21651970 ↗MalfunctionAug 23, 2024Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem
IT WAS REPORTED BY CUSTOMER THAT UNKNOWN YELLOW SUBSTANCE ON THE PACKAGE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20052165 ↗InjurySep 29, 2022Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THE "PATIENT HAD POWERGLIDE INSERTED IN THE BRACHIAL VEIN FOR ALMOST A MONTH. CONTACT WAS ALERTED THAT THE CATHETER HAS COMPLETELY FRACTURED AT THE DISTAL END OF THE CATHETER. NURSE REMOVED CATHETER HUB BUT VASCULAR DECIDED TO LEAVE THE CATHETER IN PLACE AND MONITOR IT FROM OUTPATIENT AND ONLY REMOVE IF NECESSARY. THEY HAD NOT BEEN USING THE CATHETER FOR A FEW WEEKS AND THE PATIENT IS ACTIVE IN A WHEELCHAIR."
Patient problems: Foreign Body In Patient
MAUDE report 15506796 ↗MalfunctionNov 6, 2019Activation Problem; Activation Problem
IT WAS REPORTED THAT IT WAS A REGULAR INSERTION AND UPON PULLING OUT THE SAFETY CAP CAME OFF INSTEAD OF REMAINING OVER THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9285378 ↗MalfunctionMay 16, 2019Malposition of Device
IT WAS REPORTED THAT POWERGLIDE WAS INSERTED BY WRITER INTO PATIENT'S LEFT BASILIC VEIN WITH ULTRASOUND. AFTER CATHETER WAS DEPLOYED AND NEEDLE REMOVED THE GUIDEWIRE "UNRAVELED" AND THE TIP BECAME LODGED IN THE MID SECTION OF THE CATHETER THUS PULLING THE WHOLE CATHETER BACK OUT OF THE VEIN. PRESSURE WAS HELD AND HOMEOSTASIS TO THE VEIN WAS ACHIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8617233 ↗MalfunctionMar 29, 2019Break
IT WAS REPORTED THAT THE POWERGLIDE CATHETERS SHEARED ON THE NEEDLE DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8465275 ↗
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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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