PowerGlide Pro PCK00005Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741215865), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Component” (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 16, 2026.
Most reported problems
Device problems
- Defective Component1
- Material Frayed1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2023Material Frayed; Defective Component; Material Frayed; Defective Component
IT WAS REPORTED BY CUSTOMER THAT POWERGLIDE MIDLINE 18 GAUGE 8CM GUIDE WIRE CAME OFF IN PATIENT. PATIENT WAS SENT TO NEARBY HOSPITAL EMERGENCY ROOM TO HAVE IMAGING TO EVALUATE. ADDITIONAL INFO FROM CUSTOMER: (03-AUG-2023). PT NEEDED TO BE TRANSFERRED TO ER FOR SCANS. DISCOVERED AFTER MIDLINE PLACEMENT WHEN NEEDLE WAS PULLED OUT OF PATIENT¿S ARM AND THE GUIDE WIRE WAS MISSING. UNKNOWN IF IT BROKEN IN MULTIPLE PIECES. IT WAS NEVER RECOVERED. IMAGES WERE TAKEN IN ER AND NOTHING SHOWED UP ON IMAGES. PATIENT JUST RECEIVED OUTSIDE REFERRAL FOR FURTHER SCANS AND IMAGES IN HER HOMETOWN. PATIENTS WAS ALREADY NERVOUS BEFORE MIDLINE, SO THE EVENT MADE IT EVEN WORSE. NO OTHER NEGATIVE OUTCOMES TO DATE.
Patient problems: Foreign Body In Patient
MAUDE report 17493549 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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