Peripheral Catheter Insertion Kit F120081Recalls & reported problems
Bard Access Systems, Inc. · DOT PFlex, 20G 8cm Full · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741110573), received between Aug 16, 2017 and Jun 30, 2021 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Kinked” (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.
Most reported problems
Device problems
- Kinked2
- Material Twisted/Bent2
- Break1
- Detachment Of Device Component1
- Difficult to Remove1
- Entrapment of Device1
- Failure to Advance1
- Hole In Material1
Patient problems
- No Known Impact Or Consequence To Patient3
- Pain3
- Foreign Body In Patient2
- No Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2021Material Frayed; Material Frayed
IT WAS REPORTED "THE GUIDEWIRE BROKE OFF INSIDE A PATIENT DURING ATTEMPTED MIDLINE PLACEMENT. THIS HAS RESULTED IN THE PATIENT HAVING TO HAVE SURGERY AND MULTIPLE IMAGING STUDIES." ADDITIONAL INFORMATION RECEIVED 06/14/2021: "WAS THERE PATIENT HARM REPORTED?: YES. HAD TO HAVE MULTIPLE IMAGING STUDIES TO SEARCH FOR THE WIRE AND HAD SURGERY. THEY WERE NEVER ABLE TO RETRIEVE IT."
Patient problems: Foreign Body In Patient
MAUDE report 12092249 ↗MalfunctionJul 13, 2018Material Deformation
IT WAS REPORTED THAT AFTER PLACEMENT, THE MIDLINE HAD KINKED INTERNALLY AND WAS CAUSING PAIN. THE DEVICE WAS SUBSEQUENTLY REMOVED.
Patient problems: Pain
MAUDE report 7686126 ↗MalfunctionJul 12, 2018Material Twisted/Bent
IT WAS REPORTED THAT AFTER PLACEMENT, THE MIDLINE HAD KINKED INTERNALLY AND WAS CAUSING PAIN. THE DEVICE WAS SUBSEQUENTLY REMOVED. NO PATIENT HARM REPORTED.
Patient problems: Pain
MAUDE report 7682007 ↗MalfunctionJul 10, 2018Material Twisted/Bent
IT WAS REPORTED THAT AFTER PLACEMENT, THE MIDLINE HAD KINKED INTERNALLY AND WAS CAUSING PAIN. THE DEVICE WAS SUBSEQUENTLY REMOVED. NO PATIENT INJURY WAS REPORTED.
Patient problems: Pain
MAUDE report 7674299 ↗InjuryNov 3, 2017Detachment Of Device Component; Entrapment of Device; Difficult to Remove; Failure to Advance
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED HAVING A POWERGLIDE THAT SHEARED OFF. CLINICIAN REPORTED THAT AFTER INSERTION THE CATHETER SHOWED RESISTANCE. STOPPED ADVANCING AND ATTEMPTED TO PULL BACK IT SEAMED TO BE STUCK. PULLED THE NEEDLE OUT AND THEN ATTEMPTED TO RETRIEVE THE CATHETER, THE CATHETER BROKE APPROXIMATELY 4 CM WAS LEFT IN PATIENTS ARM. THE PATIENT WAS TAKEN TO IR AND THE CATHETER WAS REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 7000887 ↗MalfunctionOct 19, 2017Hole In Material
PER SALES REP, THE FACILITY REPORTED A PIN HOLE WAS FOUND IN THE POWER PRO MIDLINE CATHETER. THE CATHETER WAS REMOVED. NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6961510 ↗MalfunctionSep 28, 2017Kinked
PER SALES REP, THE FACILITY REPORTED THE POWERGLIDE PRO CATHETERS HAVE BEEN KINKING AT THE HUB AND DO NOT LAST 29 DAYS. THIS FILE ADDRESSES THE SECOND DEVICE. (B)(6) 2017 - FACILITY REPORTED TO THE TM THAT THEY ARE USING THE STATLOCK PROVIDED IN THE KIT TO SECURE THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6902846 ↗MalfunctionSep 28, 2017Kinked
PER SALES REP, THE FACILITY REPORTED THE POWERGLIDE PRO CATHETERS HAVE BEEN KINKING AT THE HUB AND DO NOT LAST 29 DAYS. THIS FILE ADDRESSES THE FIRST DEVICE. ON 9/15/2017 - FACILITY REPORTED TO THE TM THAT THEY ARE USING THE STATLOCK PROVIDED IN THE KIT TO SECURE THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6902842 ↗InjuryAug 16, 2017Break
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAD A POWERGLIDE PRO MIDLINE CATHETER THAT WAS BEING REMOVED FROM THE PATIENT AND THE CATHETER BROKE AWAY FROM THE HUB. THE CATHETER HAD TO BE SURGICALLY REMOVED FROM THE PATIENT.
Patient problems: No Information
MAUDE report 6799250 ↗
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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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