Peripheral Catheter Insertion Kit F118100Recalls & reported problems
Bard Access Systems, Inc. · PFlex, 18G 10cm Basic Kit · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is Bard's PFlex peripheral catheter insertion kit, used to place short-term catheters into veins. The 67 reports mostly describe the catheter tip splitting open ("fish-mouthing") or softening so it will not go into the vein, a shaft that bends or breaks during insertion, and small pieces breaking off and remaining in the patient, along with pain at the insertion site. Ten reports involve injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741110511), received between Nov 23, 2016 and Oct 13, 2022 — classified as 10 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Defective Component” (44 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
- Defective Component44
- Break6
- Failure to Advance4
- Improper or Incorrect Procedure or Method4
- Unraveled Material3
- Material Frayed2
- Material Puncture/Hole2
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient20
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient4
- Pain3
- Device Embedded In Tissue or Plaque2
- Exposure to Body Fluids2
- Hematoma2
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2022Defective Component; Defective Component
IT WAS REPORTED "CATHETER IS "FISH MOUTHING" ON INSERTION AND PREVENTING THE CATHETER FROM BEING INSERTED INTO THE VEIN. THE CATHETER MATERIAL SOFTENS ON INSERTION AND CAUSING THE CATHETER TIP TO WIDEN "FISH MOUTH". FOUR DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15601834 ↗MalfunctionOct 13, 2022Defective Component; Defective Component
IT WAS REPORTED "CATHETER IS "FISH MOUTHING" ON INSERTION AND PREVENTING THE CATHETER FROM BEING INSERTED INTO THE VEIN. THE CATHETER MATERIAL SOFTENS ON INSERTION AND CAUSING THE CATHETER TIP TO WIDEN "FISH MOUTH". FOUR DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15601722 ↗MalfunctionOct 13, 2022Defective Component; Defective Component
IT WAS REPORTED "CATHETER IS "FISH MOUTHING" ON INSERTION AND PREVENTING THE CATHETER FROM BEING INSERTED INTO THE VEIN. THE CATHETER MATERIAL SOFTENS ON INSERTION AND CAUSING THE CATHETER TIP TO WIDEN "FISH MOUTH". FOUR DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15601644 ↗MalfunctionSep 1, 2022Defective Component; Defective Component
IT WAS REPORTED "UPON STICKING PATIENT WITH PG THE PATIENT EXPERIENCED SEVERE PAIN AND THE DEVICE WOULD NOT PENETRATE THE THROUGH THE VEIN WALL. THE BEVEL WOULD ATTEMPT TO PENETRATE THE VEIN HOWEVER THE REST OF THE DEVICE WOULD NOT." (B)(6) 2022 - PHOTOGRAPHS OF THREE SAMPLES WERE RETURNED FOR EVALUATION. THE CATHETERS SHAFT EXHIBITS A DEFORMATION ON THE RETURNED SAMPLES. THIS REPORT ADDRESSES THE FIRST SAMPLE.
Patient problems: Pain
MAUDE report 15341405 ↗MalfunctionSep 1, 2022Defective Component; Defective Component
IT WAS REPORTED "UPON STICKING PATIENT WITH PG THE PATIENT EXPERIENCED SEVERE PAIN AND THE DEVICE WOULD NOT PENETRATE THE THROUGH THE VEIN WALL. THE BEVEL WOULD ATTEMPT TO PENETRATE THE VEIN HOWEVER THE REST OF THE DEVICE WOULD NOT." (B)(6) 2022 - PHOTOGRAPHS OF THREE SAMPLES WERE RETURNED FOR EVALUATION. THE CATHETERS SHAFT EXHIBITS A DEFORMATION ON THE RETURNED SAMPLES. THIS REPORT ADDRESSES THE SECOND SAMPLE.
Patient problems: Pain
MAUDE report 15341286 ↗MalfunctionSep 1, 2022Defective Component; Defective Component
IT WAS REPORTED "UPON STICKING PATIENT WITH PG THE PATIENT EXPERIENCED SEVERE PAIN AND THE DEVICE WOULD NOT PENETRATE THE THROUGH THE VEIN WALL. THE BEVEL WOULD ATTEMPT TO PENETRATE THE VEIN HOWEVER THE REST OF THE DEVICE WOULD NOT." (B)(6) 2022 - PHOTOGRAPHS OF THREE SAMPLES WERE RETURNED FOR EVALUATION. THE CATHETERS SHAFT EXHIBITS A DEFORMATION ON THE RETURNED SAMPLES. THIS REPORT ADDRESSES THE THIRD SAMPLE.
Patient problems: Pain
MAUDE report 15341242 ↗InjuryMay 20, 2022Break; Break
IT WAS REPORTED "SMALL PIECE OF THE CATHETER BROKE OFF DURING A FAILED INSERTION." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 14461282 ↗MalfunctionMay 13, 2022Difficult to Insert; Difficult to Insert
IT WAS REPORTED "SUPERVISOR AS WELL AS A LINES INSERTER CALLED ME TO LET ME KNOW THAT THE PRODUCT ABOVE WAS FAULTY. SHE HAS PLACED THOUSANDS OF THESE CATHETERS AND THIS ONE WOULD NOT PIERCE THROUGH THE PATIENTS SKIN. IT WAS NOT THE NEEDLE BUT APPEARED TO BE AT THE NEEDLE/CATHETER TRANSITION AREA. SHE SAID IT SEEMED LIKE A ROUGH TRANSITION AND INSTEAD OF FORCING IT, SHE ABORTED THIS PROCEDURE AND GOT A NEW PRODUCT WHICH PLACED WITH EASE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14401124 ↗MalfunctionApr 1, 2022Defective Component; Defective Component
IT WAS REPORTED "CATHETER IS "FISH MOUTHING" ON INSERTION AND PREVENTING THE CATHETER FROM BEING INSERTED INTO THE VEIN. THE CATHETER MATERIAL SOFTENS ON INSERTION AND CAUSING THE CATHETER TIP TO WIDEN "FISH MOUTH".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13979784 ↗MalfunctionMar 26, 2022Defective Component; Defective Component
IT WAS REPORTED "DULLNESS OF BARD POWERGLIDE PRO MIDLINE CATHETERS" ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL: "WE HAVE TO JAB THE PATIENT VERY HARD, AND IT WILL NOT GO IN THE VEIN AT ALL EVEN IF WE ARE ABLE TO BREAK SKIN. THE PLASTIC PART OF THE CATHETER IS FLARED." ON (B)(6) 2022: FOUR SAMPLES WERE RETURNED. ALL FOUR SAMPLES EXHIBITED THE DISTAL TIP TO BE IRREGULAR. THE IRREGULAR TIP APPEARED TO CAUSE A ROUGH TRANSITION BETWEEN THE CATHETER TIP AND THE NEEDLE SHAFT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13922731 ↗MalfunctionMar 26, 2022Defective Component; Defective Component
IT WAS REPORTED ISSUES PIERCING THROUGH THE VEIN AND THEN HAVE TROUBLE ADVANCING THE CATHETER. IT WAS STATED, "IT FEELS LIKE I¿M TRYING TO PIERCE THE VEIN WITH A DULL NEEDLE. DESPITE HAVING A HARD TIME PIERCING THE VEIN, I CAN SEE MY NEEDLE TIP IN THE VEIN BUT CAN¿T ADVANCE THE CATHETER. I CHECK MY WIRE AND THE NEEDLE TIP BEFORE INSERTING BUT AM HAVING TO STICK MULTIPLE TIMES." NO HARM TO PATIENT. ON (B)(6) 2022: THE DISTAL END OF THE RETURNED CATHETER REVEALED DEFORMATION AND APPEARED IRREGULAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13922382 ↗MalfunctionMar 25, 2022Defective Component; Defective Component
IT WAS REPORTED "DULLNESS OF BARD POWERGLIDE PRO MIDLINE CATHETERS". ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL: "WE HAVE TO JAB THE PATIENT VERY HARD, AND IT WILL NOT GO IN THE VEIN AT ALL EVEN IF WE ARE ABLE TO BREAK SKIN. THE PLASTIC PART OF THE CATHETER IS FLARED." (B)(6) 2022: FOUR SAMPLES WERE RETURNED. ALL FOUR SAMPLES EXHIBITED THE DISTAL TIP TO BE IRREGULAR. THE IRREGULAR TIP APPEARED TO CAUSE A ROUGH TRANSITION BETWEEN THE CATHETER TIP AND THE NEEDLE SHAFT. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13907556 ↗MalfunctionMar 25, 2022Defective Component; Defective Component
IT WAS REPORTED "DULLNESS OF BARD POWERGLIDE PRO MIDLINE CATHETERS". ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL: "WE HAVE TO JAB THE PATIENT VERY HARD, AND IT WILL NOT GO IN THE VEIN AT ALL EVEN IF WE ARE ABLE TO BREAK SKIN. THE PLASTIC PART OF THE CATHETER IS FLARED." (B)(6) 2022: FOUR SAMPLES WERE RETURNED. ALL FOUR SAMPLES EXHIBITED THE DISTAL TIP TO BE IRREGULAR. THE IRREGULAR TIP APPEARED TO CAUSE A ROUGH TRANSITION BETWEEN THE CATHETER TIP AND THE NEEDLE SHAFT. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13907551 ↗MalfunctionMar 25, 2022Defective Component; Defective Component
IT WAS REPORTED "DULLNESS OF BARD POWERGLIDE PRO MIDLINE CATHETERS" ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL: "WE HAVE TO JAB THE PATIENT VERY HARD, AND IT WILL NOT GO IN THE VEIN AT ALL EVEN IF WE ARE ABLE TO BREAK SKIN. THE PLASTIC PART OF THE CATHETER IS FLARED." ON (B)(6) 2022: FOUR SAMPLES WERE RETURNED. ALL FOUR SAMPLES EXHIBITED THE DISTAL TIP TO BE IRREGULAR. THE IRREGULAR TIP APPEARED TO CAUSE A ROUGH TRANSITION BETWEEN THE CATHETER TIP AND THE NEEDLE SHAFT. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13907548 ↗MalfunctionMar 25, 2022Defective Component; Defective Component
IT WAS REPORTED "DULLNESS OF BARD POWERGLIDE PRO MIDLINE CATHETERS" ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL " WE HAVE TO JAB THE PATIENT VERY HARD, AND IT WILL NOT GO IN THE VEIN AT ALL EVEN IF WE ARE ABLE TO BREAK SKIN. THE PLASTIC PART OF THE CATHETER IS FLARED." (B)(6) 2022: THE RETURNED CATHETER REVEALED THE DISTAL TIP TO BE IRREGULAR. THE IRREGULAR TIP APPEARED TO CAUSE A ROUGH TRANSITION BETWEEN THE CATHETER TIP AND THE NEEDLE SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13906805 ↗MalfunctionMar 18, 2022Defective Component; Defective Component
IT WAS REPORTED VIA MEDWATCH "PICC LINE TRAINED STAFF ATTEMPTED TO INSERT MIDLINE X 2, MIDLINE NOTED WITH FLARED TIP AND UNABLE TO ADVANCE INTO VEIN 2ND ATTEMPT SUCCESSFUL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13809204 ↗MalfunctionMar 18, 2022Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE GUIDEWIRE IN THE POWERGLIDE BROKE DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13808666 ↗MalfunctionMar 11, 2022Defective Component; Defective Component
IT WAS REPORTED "NEEDLE IS DULL, DIFFICULT TO PUNCTURE VEIN." ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED "FACILITY USES POWERGLIDE PRO NOT THE RT REINFORCED TIP. THE CATHETER IS POSSIBLY FISH MOUTHING WHEN THEY ADVANCE, GIVING THE IMPRESSION THAT THE NEEDLE IS DULL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13736901 ↗MalfunctionFeb 24, 2022Defective Component; Defective Component
IT WAS REPORTED "PG FEEL DULL AND WON'T PUNCTURE SKIN." (B)(6) 2022-THREE DEVICES WERE RETURNED FOR EVALUATION. EACH DEVICE EXHIBITED ROUGH/SPLIT TRANSITIONS BETWEEN THE CATHETER TIPS AND NEEDLE SHAFTS. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595698 ↗MalfunctionFeb 24, 2022Defective Component; Defective Component
IT WAS REPORTED "PG FEEL DULL AND WON'T PUNCTURE SKIN." (B)(6) 2022-THREE DEVICES WERE RETURNED FOR EVALUATION. EACH DEVICE EXHIBITED ROUGH/SPLIT TRANSITIONS BETWEEN THE CATHETER TIPS AND NEEDLE SHAFTS. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595696 ↗MalfunctionFeb 24, 2022Defective Component; Defective Component
IT WAS REPORTED "PG FEEL DULL AND WON'T PUNCTURE SKIN." (B)(6) 2022-THREE DEVICES WERE RETURNED FOR EVALUATION. EACH DEVICE EXHIBITED ROUGH/SPLIT TRANSITIONS BETWEEN THE CATHETER TIPS AND NEEDLE SHAFTS. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595654 ↗MalfunctionJan 6, 2022Activation Problem; Activation Problem
IT WAS REPORTED "THE NEEDLE SAFETY DIDN¿T WORK CAUSING POTENTIAL FOR NEEDLE STICK." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13185753 ↗MalfunctionNov 12, 2021Defective Component; Defective Component
IT WAS REPORTED 2 INSTANCES OF CATHETERS HAVING BLUNT TIPS LEADING BENDING AND FAILURE OF PLACING LINE. ADD INFO RCVD (B)(6) 2021: NONE OF THE HEMATOMAS REQUIRED SURGICAL INTERVENTION. PLACEMENT INFO: DULL TIP, UNABLE TO PLACE. WAS THERE PATIENT HARM REPORTED?: HEMATOMA AT SITE. WHAT THEY¿RE BEING TREATED FOR: HEMOLYTIC UREMIC SYNDROME. MEDWATCH MW5103282 RCVD (B)(6) 2021: BARD MIDLINE 18G POWERGLIDE PRO, BLUNT END, 2 FAILED ATTEMPTS DUE TO DEFECT OF BLUNT TIP TO CATHETER, SUCCESSFUL 3RD ATTEMPT. (B)(6) 2021: ONE SAMPLE WAS RETURNED TO THE MANUFACTURER. THE RETURNED SAMPLE EXHIBITED AN OUTWARD FLARING CATHETER TIP.
Patient problems: Hematoma
MAUDE report 12804881 ↗MalfunctionNov 12, 2021Defective Component; Defective Component
IT WAS REPORTED 2 INSTANCES OF CATHETERS HAVING BLUNT TIPS LEADING BENDING AND FAILURE OF PLACING LINE. ADD INFO RCVD (B)(6) 2021: NONE OF THE HEMATOMAS REQUIRED SURGICAL INTERVENTION. PLACEMENT INFO: DULL TIP, UNABLE TO PLACE. WAS THERE PATIENT HARM REPORTED?: HEMATOMA AT SITE. WHAT THEY¿RE BEING TREATED FOR: HEMOLYTIC UREMIC SYNDROME. MEDWATCH MW5103282 RCVD (B)(6) 2021: BARD MIDLINE 18G POWERGLIDE PRO, BLUNT END, 2 FAILED ATTEMPTS DUE TO DEFECT OF BLUNT TIP TO CATHETER, SUCCESSFUL 3RD ATTEMPT. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Hematoma
MAUDE report 12804766 ↗MalfunctionOct 13, 2021Defective Component; Defective Component
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "THE WIRE WAS COILED UP VERY BADLY. POWERGLIDE PLACEMENT WAS NORMAL. NURSE IS VERY EXPERIENCED WITH ACCUCATH AND POWERGLIDE." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12629129 ↗
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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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