Peripheral Catheter Insertion Kit F120087TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 20Ga, 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741140471), received between Aug 13, 2020 and Aug 9, 2023 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Improper or Incorrect Procedure or Method3
- Activation Problem1
Patient problems
- Foreign Body In Patient3
- No Consequences Or Impact To Patient1
- Thrombosis/Thrombus1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
CUSTOMER REPORTED: "ON (B)(6) 2023 RN ATTEMPTED TO ACCESS CEPHALIC VEIN WITH POWERGLIDE PRO 20G 8CM CATHETER USING ULTRASOUND. ON ASSESSMENT VEIN EASILY COMPRESSIBLE AND ABLE TO ACCOMMODATE SIZE OF CATHETER. CATHETER TIP APPEARED TO BE IN CENTER OF VESSEL, RN ADVANCED THE GUIDEWIRE WITH NO RESISTANCE. RN PROCEEDED TO ADVANCE CATHETER AND FELT RESISTANCE ALMOST IMMEDIATELY. BECAUSE GUIDEWIRE WAS ALREADY INSERTED, RN DEPLOYED CATHETER WITHOUT ADVANCING (MOVED HOUSING AWAY FROM PATIENT WHILE DEPLOYING CATHETER). RN KNEW CATHETER WAS NOT IN CORRECT PLACE THEREFORE ATTEMPTED TO REMOVE CATHETER, RESISTANCE WAS MET SO RN STOPPED AND WAITED A FEW MINUTES WHILE ANOTHER RN WENT TO GET HEAT. AFTER A FEW MINUTES RN WAS ABLE TO REMOVE CATHETER WITHOUT HEAT. TIP OF CATHETER DID NOT APPEAR INTACT AND ABOUT 1CM WAS MISSING. XRAY OBTAINED SHOWED ¿ ¿FINDINGS MOST COMPATIBLE WITH SMALL RETAINED FOREIGN BODY WITHIN THE ANTERIOR LATERAL SOFT TISSUES OF THE DISTAL UPPER ARM¿. INTERVENTIONAL RADIOLOGY ATTEMPTED REMOVAL VIA ULTRASOUND AND WAS UNSUCCESSFUL AND CLIPPED VEIN ABOVE CATHETER TIP. PER IR ¿ ¿BASED ON THE FOREIGN BODIES POSITION AND SMALL SIZE OF THE CEPHALIC VEIN AND ASSOCIATED THROMBOSIS I BELI
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 17491173 ↗InjuryMay 25, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED, WRITER WAS PLACING A MIDLINE ON PATIENT. WRITER WAS USING POWERGLIDE PRO 20G 8CM. REF F120087T LOT REGW1332 WRITER PLACED MIDLINE IN VESSEL, ADVANCED THE GUIDEWIRE WITH NO RESISTANCE, THEN PROCEEDED TO ADVANCE THE CATHETER BUT MET RESISTANCE ONCE ABOUT 4 CM WAS ADVANCED. WRITER REMOVED THE MIDLINE, AND THE PATIENT WAS FOUND TO STILL HAVE ABOUT 4 CM OF CATHETER STILL IN THEIR ARM. MD NOTIFIED.
Patient problems: Foreign Body In Patient
MAUDE report 17008213 ↗InjurySep 30, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED BY THE CUSTOMER A POWERGLIDE PRO RT CATHETER FRACTURE INSIDE A PATIENT. CATHETER WAS REMOVED SUCCESSFULLY AND RECOVERED BY THE PHYSICIAN."
Patient problems: Foreign Body In Patient
MAUDE report 15521074 ↗MalfunctionAug 13, 2020Activation Problem; Activation Problem
IT WAS REPORTED THE SAFETY OF THE NEEDLE GOT STUCK IN THE STOPPER, LEFT TIP OF NEEDLE EXPOSED. ADDITIONAL INFORMATION RECEIVED 7/29/2020: PICC WAS PLACED IN THE LEFT BASILIC. THE SAFETY GOT STUCK IN THE TIP RESERVOIR WHEN THE NEEDLE WAS WITHDRAWN, LEAVING AN EXPOSED SHARP/TIP OF THE NEEDLE. THERE WAS NO HARM TO THE PATIENT, BUT AN INCREASED RISK TO THE USER. THE MIDLINE WAS PLACED OTHERWISE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10405315 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page