Peripheral Catheter Insertion Kit F120100Recalls & reported problems
Bard Access Systems, Inc. · PFlex, 20G 10cm Basic Kit · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741110535), received between May 18, 2017 and Sep 10, 2021 — classified as 2 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Device Operates Differently Than Expected3
- Physical Resistance/Sticking3
- Fluid/Blood Leak2
- Improper or Incorrect Procedure or Method2
- Physical Resistance2
- Bent1
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "POWERGLIDE CATHETER [WAS] LEAKING RIGHT WHERE THE PINK HUB MEETS THE CATHETER. THE CATHETER WAS PLACED IN THE LEFT UPPER BASILIC VEIN THEN ASPIRATED FOR BLOOD." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12454381 ↗InjuryDec 23, 2020Break; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT PATIENT ACCESSING VESSEL WITH A POWERGLIDE. WIRE RAN SMOOTHLY, PER NURSE PLACING DEVICE. CATHETER DEPLOYED AND RESISTANCE MET. THERE MAY HAVE BEEN SOME MANIPULATION OF THE WIRE AND CATHETER BACK AND FORTH AFTER RESISTANCE FELT. WIRE AND DEVICE REMOVED WHILE CATHETER REMAINED IN THE PATIENT'S ARM. CATHETER GOT STUCK IN THE PATIENT'S SKIN WHEN LAST CENTIMETER OF CATHETER WAS TRYING TO BE REMOVED. LAST CENTIMETER OF CATHETER BROKE OFF UNDER PATIENT¿S SKIN. THAT PART OF THE CATHETER WAS REMOVED FROM THE PATIENT¿S ARM SAFELY.
Patient problems: Foreign Body In Patient
MAUDE report 11069329 ↗MalfunctionDec 4, 2020Break
IT WAS REPORTED "NURSE PRACTITIONER REPORTS THAT THEY ATTEMPTED TO INSERT POWERGLIDE PRO, PRODUCT CODE F120100, LOT REEP0565 INTO A PATIENTS CEPHALIC VEIN AND HIT AN OBSTRUCTION. THE MIDLINE WAS REMOVED AND THE LAST 3 CMS WERE MISSING. THE INSERTED USED THE CEPHALIC VEIN. PATIIENT WEIGHS 102 KGS. IS THE DEVICE RADIOPAQUE WE CANNOT SEE IT ON X-RAY?" RESPONSE: "THE POWERGLIDE HAS 6 SMALL RADIOPAQUE STRIPES ALONG THE LENGTH. RECOMMENDED THEY TRY ULTRASOUND. CALLED HER BACK AND SHE REPORTS THAT THEY CAN SEE THE BROKEN PIECE IN THE CEPHALIC AND THERE IS ALSO A CLOT. THEY BELIEVE THE CLOT WAS THE OBSTRUCTION. SHE STATED THE PATIENT WILL NEED SURGERY FOR REMOVAL OF THE PIECE." "THE PATIENT WILL REQUIRE SURGERY TO REMOVE THE FRAGMENT IN THE ARM." ADDITIONAL DETAILS RECEIVED 11/13/2020: " ONE OF OUR NEW MIDLINE INSERTERS WAS ATTEMPTING TO PLACE THE POWERGLIDE IN A MALE CANCER PT. I BELIEVE THE NEEDLE WAS DEPLOYED, NURSE HAD BLOOD RETURN, THE CATHETER WAS NOT FEEDING SMOOTHLY AND SHE PULLED BACK ON THE WINGS, PROBABLY SHEARING OFF THE CATHETER TIP ( 4CM). WE WERE ABLE TO RETRIEVE IT SURGICALLY. IT WAS PARTIALLY IN THE VEIN, BUT MAINLY OUT IN THE SOFT TISSUE AND WAS KINKED. INTERESTINGLY, OUR
Patient problems: Foreign Body In Patient
MAUDE report 10950173 ↗MalfunctionApr 20, 2020Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING INSERTION RESISTANCE WAS MET WHEN THREADING. THEN THE INSERTER REMOVED THE ENTIRE UNIT AND THE WIRE AND CATHETER WAS SHEARED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9979797 ↗MalfunctionMar 22, 2019Leak/Splash
IT WAS REPORTED THAT A BLOOD LEAK WAS NOTICED BETWEEN THE HUB AND THE CATHETER. IT WAS REMOVED AND A NEW ONE WAS PLACED AND NO LEAKING WAS NOTICED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8444770 ↗MalfunctionDec 21, 2018Break
IT WAS REPORTED THAT A POWERGLIDE PRO MIDLINE CATHETER 20 GA WIRE BROKE OFF IN PATIENT. IT WAS STATED PATIENT WAS UNHARMED AND ALL PARTS WERE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8189575 ↗MalfunctionDec 18, 2018Break; Detachment of Device or Device Component; Physical Resistance/Sticking
BARD POWERGLIDE PRO MIDLINE CATHETER 20 GA REF# (B)(4), LOT# RECV0748 WIRE BROKE OFF IN PATIENT. PATIENT WAS UNHARMED AND ALL PARTS WERE REMOVED. MANUFACTURER RESPONSE FOR MIDLINE, POWERGLIDE PRO MIDLINE CATHETER (PER SITE REPORTER): SALES REPRESENTATIVE WILL FILE REPORT WITH BARD QA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8174550 ↗MalfunctionDec 13, 2018Break
IT WAS REPORTED THAT THE POWERGLIDE BROKEN WHILE INSERTING INTO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8163065 ↗MalfunctionAug 9, 2018Physical Resistance/Sticking
IT WAS REPORTED THAT THE PATIENT WAS AN IV DRUG ABUSER WITH VERY TOUGH VASCULATURE. IT WAS REPORTED THAT THE NEEDLE HAD A DIFFICULT TIME TRYING TO ENTER THE VEIN, AND THE GUIDEWIRE WAS DEPLOYED BUT MET RESISTANCE. THE CLINICIAN WENT TO WITHDRAW THE WIRE AND FELT A SNAG ON THE WIRE, STOPPED AND PULLED ENTIRE DEVICE BACK AS ONE UNIT. A NEW DEVICE WAS PLACED THE NEXT DAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7770703 ↗MalfunctionJun 29, 2018Peeled/Delaminated
IT WAS REPORTED THAT THE POWERGLIDE WIRE LOOKED STRIPPED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7651905 ↗MalfunctionApr 12, 2018Bent; Retraction Problem; Malposition of Device
IT WAS REPORTED THAT THE DEVICE OPERATOR TRIED TO ADVANCE THE GUIDE WIRE AND CATHETER WHEN THEY WERE NOT IN THE CORRECT POSITION. WHEN THIS WAS UNSUCCESSFUL, IT WAS SATED THAT THE DEVICE OPERATOR COULD NOT RETRACT THE GUIDE WIRE. THE COMPLAINANT THEN ATTEMPTED TO REMOVE IT WITHOUT SUCCESS. IT WAS REPORTED THAT THE RADIOLOGIST "TUGGED 4 TO 5 TIMES" AND REMOVED THE DEVICE. IT WAS NOTED THAT THE WIRE WAS CURLED AND THE CATHETER WAS BENT UPON REMOVAL.
Patient problems: No Information
MAUDE report 7426353 ↗MalfunctionDec 14, 2017Physical Resistance
FACILITY REPORTED TO SALES REP THAT AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO PLACE THE CATHETER THE PHYSICIAN DECIDED TO REMOVE THE GUIDEWIRE AND ATTEMPT TO PLACE THE DEVICE IN A DIFFERENT LOCATION. WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE THE PHYSICIAN MET RESISTANCE, HE CONTINUED TO TRY AND REMOVE THE GUIDEWIRE BUT IT WAS STATED THAT THE GUIDEWIRE "GOT STUCK." THE GUIDEWIRE WOULDN'T COME OUT UNTIL THE PHYSICIAN USED "EXCESSIVE FORCE" AND THEN "EVERYTHING WAS PULLED OUT OF THE PATIENT'S ARM." NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7117021 ↗MalfunctionDec 6, 2017Material Fragmentation; Physical Resistance
IT WAS REPORTED BY THE FACILITY THAT WHILE THE NURSE WAS PLACING THE DEVICE THE WIRE WAS DEPLOYED SUCCESSFULLY AND AS THE NURSE WAS PULLING THE CATHETER BACK HE MET RESISTANCE. IT WAS NOTED THAT THE CATHETER BROKE SUBCUTANEOUSLY AT THE 2CM MARK. ULTRASOUND WAS DONE AND THE CATHETER WAS NOT VISIBLE. THE PHYSICIAN MADE THE DECISION TO LEAVE THE CATHETER AT THIS POINT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7087801 ↗InjuryJul 18, 2017Detachment Of Device Component; Device Operates Differently Than Expected
THE FACILITY REPORTED DIFFICULTY IN THREADING THE MIDLINE CATHETER DURING PLACEMENT. IT WAS STATED THAT AFTER UNSUCCESSFUL ATTEMPT, IT WAS NOTED THAT THE CATHETER WAS SHORTER WHEN PULLED OUT OF THE PATIENT'S RIGHT ARM. X-RAY CONFIRMED RETAINED CATHETER FRAGMENT. SURGEON PERFORMED SUCCESSFUL FOREIGN BODY RETRIEVAL.
Patient problems: Foreign Body In Patient
MAUDE report 6721625 ↗MalfunctionJun 23, 2017Device Operates Differently Than Expected
IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT THE NURSE TRIED TO THREAD THE GUIDEWIRE AND CATHETER AND THE NEEDLE WENT THROUGH THE GUIDEWIRE AND THE CATHETER. NO OTHER INFORMATION WAS PROVIDED. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6663917 ↗MalfunctionMay 18, 2017Device Or Device Fragments Location Unknown; Device Operates Differently Than Expected
PER SALES REP, THE FACILITY REPORTED THAT THE PICC RN PLACED A 20G POWERGLIDE PRO AND WHEN REMOVING THE HOUSING AFTER PLACEMENT, NOTICED THAT THE GUIDEWIRE WAS NOT STICKING OUT BEYOND THE SAFETY MECHANISM. IT WAS STATED THAT THE RN WAS UNSURE IF GUIDEWIRE WAS PRESENT BEFORE PROCEDURE AND UNSURE IF GUIDEWIRE WAS LEFT IN PATIENT. THE FACILITY IS STILL LOOKING INTO THE MATTER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6575080 ↗
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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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