PowerGlide F120101TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide Pro with Reinforced Tip, 20G 10cm, Full Kit · Class 2
All models of PowerGlide (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741142727), received between Feb 8, 2022 and Apr 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MS&S "CALLER STATES HE PLACED A POWERGLIDE PRO AND AFTER FLUSHING THE FLUID AND BLOOD IS LEAKING AROUND THE PINK HUB AND CATHETER CONNECTION. THERE WAS NO KINKING AT INSERTION AND WAS NOT A DIFFICULT INSERTION. THERE WAS NO SEPARATION OF THE CATHETER PRIOR TO INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251161 ↗MalfunctionFeb 8, 2022Material Deformation; Material Deformation
IT WAS REPORTED VIA MS&S " CALLER STATES SHE IS A HOME HEALTH NURSE WORKING WITH A PATIENT THAT HAS A POWERGLIDE MIDLINE PRODUCT CODE F120101T (REFV1538). CALLER STATES SHE TOOK OFF THE DRESSING FOR THE DEVICE AND THE CATHETER WAS KINKED. SHE STATES SHE ADJUSTED THE CATHETER AND REINSERTED IT A LITTLE BACK INTO THE VEIN. CALLER STATES SHE CANNOT GET A BLOOD RETURN FROM THIS MIDLINE. CALLER ASKING WHAT IS BD'S RECOMMENDATION FOR RE-INSERTING THE MIDLINE. SHOULD I GIVE THE PATIENT ANTIBIOTICS?" MS&S EXPLAINED THAT BD DOES NOT HAVE A RECOMMENDATION TO REINSERT A MIDLINE CATHETER IF SOME OF THE CATHETER SLIDES OUT. DISCUSSED BLOOD FLOW IN THE VEINS OF THE UPPER ARMS. MIDLINE CATHETERS ARE PERIPHERAL CATHETERS. BLOOD RETURN IN MIDLINES IS NOT AN INDICATION THAT THE MIDLINE IS IN OR OUT OF THE VEIN. EXPLAINED THAT SHE SHOULD FOLLOW HER FACILITY'S PROTOCOL FOR MIDLINES AND HOW TO PROCEED. THIS SHOULD INCLUDE CONTACTING THE PHYSICIAN FOR FURTHER GUIDANCE. IMAGING THE CATHETER MAY BE NECESSARY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13488505 ↗
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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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