Peripheral Catheter Insertion Kit F120101Recalls & reported problems
Bard Access Systems, Inc. · DOT PFlex, 20G 10cm Full · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741110580), received between Feb 28, 2017 and Sep 10, 2021 — classified as 3 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Kinked” (4 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 16, 2026.
Most reported problems
Device problems
- Kinked4
- Bent2
- Failure to Advance2
- Hole In Material2
- Component Missing1
- Device Damaged by Another Device1
- Fluid/Blood Leak1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Known Impact Or Consequence To Patient9
- Device Embedded In Tissue or Plaque2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT IS WAS REPORTED THE HEALTH PROFESSIONAL INSERTED A POWERGLIDE CATHETER; WHEN SHE WENT TO FLUSH, IT LEAKED AT THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455502 ↗InjuryMar 22, 2019Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE POWERGLIDE "MALFUNCTIONED". REQUESTING MORE INFORMATION. (B)(6)2019 : PICC NURSE INSERTED PICC INTO BASILIC VEIN RIGHT ARM AND DID NOT INSERT CORRECTLY. THE WIRE DID NOT GO ALL THE WAY IN BEFORE INSERTING THE CATHETER. CATHETER WAS ADVANCED AND A DOUBLE CLICK WAS HEARD AND BOTH THE CATHETER AND WIRE WERE DISLODGED AND GOT STUCK IN THE PATIENT. PATIENT WAS ADMITTED FOR FLU, FEVER, AND SEIZURES. 3CM OF CATHETER AND WIRE ARE RETAINED IN HER. RADIOLOGY WAS REQUESTED TO LOOK INTO THE INSERTED WIRE AND CATHETER. ADDT'L INFORMATION VIA MEDWATCH (B)(6)2019 : ON FEB 28TH, POWERGLIDE INSERTION ATTEMPTED ON RIGHT BASILICA VEIN IN LOWER PORTION OF THE UPPER ARM. NEEDLE WAS INSERTED INTO VEIN WITHOUT COMPLICATION BUT UPON GUIDEWIRE INSERTION, A POPPING SOUND WAS HEARD WITH SOME RESISTANCE. CATHETER ABLE TO BE ADVANCED AROUND 2-3 CM, BUT THEN STOPPED. MIDLINE COULD NOT BE ADVANCED ANY FURTHER. MIDLINE WAS PULLED OUT WITH EASE. UPON INSPECTION OF CATHETER, ABOUT 3 CM OF CATHETER AND WIRE WERE MISSING. PRIMARY NURSE, INTENSIVIST, AND PT'S DAUGHTER WERE NOTIFIED IN PERSON OF OCCURRENCE. BARD REP WAS GIVEN THE POWERGLIDE ON THE DATE OF OCCURRENCE. ON MARCH 5TH WAS THE REMOVA
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8444835 ↗InjuryOct 5, 2018Failure to Advance; Physical Resistance/Sticking
IT WAS REPORTED THAT THE NURSE ATTEMPTED TO PLACE THE MIDLINE IN THE RIGHT UPPER ARM. ULTRASOUND WAS USED TO GUIDE THE NEEDLE IN THE VEIN. AFTER OBTAINING BLOOD RETURN, THE CATHETER WAS UNABLE TO BE ADVANCED. THE NURSE REPORTEDLY WAS ALSO UNABLE TO PULL THE CATHETER BACK. THE NURSE ATTEMPTED TO FLUSH THE CATHETER AND SALINE CAME OUT OF THE SIDE OF THE CATHETER. UPON INSPECTION, THERE WAS A REPORTED CRACK ON THE CATHETER AND IT WAS STUCK IN THE SUBCUTANEOUS FAT. A SMALL INCISION WAS MADE AND THE CATHETER WAS REMOVED WITHOUT DIFFICULTY. A NEW MIDLINE WAS PLACE SUCCESSFULLY IN THE LEFT UPPER ARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7939562 ↗MalfunctionApr 23, 2018Kinked
IT WAS REPORTED THAT THERE WAS AN INTERNAL KINK IN THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7450687 ↗MalfunctionApr 23, 2018Kinked
IT WAS REPORTED THAT THERE WAS AN INTERNAL KINK AT A 90 DEGREE ANGLE 2 CM FROM THE TIP OF THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7450642 ↗MalfunctionApr 19, 2018Component Missing; Device Damaged by Another Device
IT WAS REPORTED THAT THE GUIDEWIRE WAS MISSING. NO PATIENT INJURY REPORTED, ONLY REQUIRED ADDITIONAL STICKS. ON 03/26/2018- EVALUATION FOUND THAT THE NEEDLE PUNCTURED THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7444879 ↗InjuryJan 3, 2018Material Fragmentation; Physical Resistance
IT WAS REPORTED THAT DURING PLACEMENT, THE POWERGLIDE PRO GOT BLOOD RETURN SO THEY ADVANCED THE CATHETER. THEY FELT RESISTANCE AND DECIDED TO RETRACT THE GUIDEWIRE AND PULLED THE ENTIRE DEVICE OUT. AFTER THEY HAD REMOVED THE DEVICE THEY NOTICED HALF OF THE CATHETER WAS MISSING. VASCULAR SURGERY FOUND THE CATHETER IN THE TISSUE OF THE PATIENT, AT THAT TIME THE DECISION WAS MADE NOT TO REMOVE THE PIECE OF CATHETER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7162778 ↗MalfunctionSep 29, 2017Kinked
PER SALES REP, THE FACILITY REPORTED THE POWERGLIDE PRO CATHETERS HAVE BEEN KINKING AT THE HUB AND DO NOT LAST 29 DAYS. PATIENT 1.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6903797 ↗MalfunctionSep 29, 2017Kinked
PER SALES REP, THE FACILITY REPORTED THE POWERGLIDE PRO CATHETERS HAVE BEEN KINKING AT THE HUB AND DO NOT LAST 29 DAYS. PATIENT 2.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6903796 ↗MalfunctionAug 4, 2017Bent; Material Integrity Problem
IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT THEY HAD A MIDLINE WITH A JAGGED WIRE, IT WAS IDENTIFIED BEFORE THEY ATTEMPTED TO PLACE IT. ON 07/17/17 ADDITIONAL INFORMATION RECEIVED FROM FACILITY: THE NURSE STATED THAT SHE COULD DESCRIBE THAT THE WIRE TIP WAS BENT IN ALMOST A 90 DEGREE "JAGGED" ANGLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6769470 ↗MalfunctionMay 4, 2017Hole In Material
AS REPORTED TO THE SALES REP BY THE FACILITY THE POWERGLIDE PRO HAD A HOLE IN THE CATHETER AFTER INSERTION. NO HARM OR INJURY TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6543469 ↗MalfunctionApr 27, 2017Hole In Material; Leak/Splash
RECEIVED 4/7/17- PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT THE CATHETER WAS LEAKING WITH FLUSHING, AND AT CLOSER INSPECTION, IT HAD DEVELOPED A HOLE IN THE CATHETER AT THE HUB. THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6527349 ↗MalfunctionFeb 28, 2017Bent; Sticking; Failure to Advance
IT WAS REPORTED BY THE NURSE THAT WHILE PLACING A MIDLINE AND GETTING THE TIP IN THE VEIN, SHE WAS ABLE TO GET BLOOD RETURN. SHE THEN ADVANCED THE WIRE WITHOUT INCIDENT. THE CATHETER WAS THEN DEPLOYED BUT WOULD NOT FULLY ADVANCE. THE NURSE TRIED PULLING BACK THE WIRE BUT IT BECAME STUCK. SHE GENTLY WORKED THE CATHETER OUT AND STATED THAT TOWARD THE END SHE FELT LIKE IT SNAPPED. THE WIRE CAME OUT BENT AND WAS BROKEN OFF THE MAIN SHAFT OF THE WIRE. THE CONTACT (NURSE) HAD ANOTHER PICC NURSE VERIFY THAT THE TIP WAS INTACT AND ALL WIRES MEASURED EXACTLY WHEN COMPARED TO ANOTHER POWERGLIDE CATHETER. NO HEMATOMA OR CONTINUED BLEEDING AT THE INSERTION SITE WAS NOTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6365533 ↗
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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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