Peripheral Catheter Insertion Kit F120107TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741140488), received between Sep 18, 2019 and Dec 17, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, IV PLACED ON (B)(6) 2025 @ 1632. NO ISSUES WITH PLACEMENT. NO IV CONTRAST OR POWER INJECTIONS DURING THE 7 DAYS THE IV WAS IN PLACE. DISCOVERED (B)(6) 2025 (ROUTINE DRESSING CHANGE) @ 11:00. NOTED IT WAS LEAKING AT INSERTION SITE AND REMOVED. ADDITIONAL INFORMATION (B)(6) 2025: REMOVED AND NEW ACCESS WAS PLACED - NO DELAY, JUST LEAKING AT THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829023 ↗
• MalfunctionNov 7, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE NEEDLE SAFETY MECHANISM DID NOT DEPLOY. NO ADVERSE REACTIONS AS WE DID NOT USE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497561 ↗
• MalfunctionMay 13, 2025Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER THAT POWERGLIDE LEAKING WHERE THE CATHETER MEETS THE HUB. THIS WAS NOTICED AFTER PLACEMENT AND INITIAL FLUSH. CATHETER HAD TO BE REMOVED AND REPLACED. PATIENT WAS IMPACTED BY NEED FOR ADDITIONAL STICK TO PATIENT TO REPLACE THE CATHETER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011318 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER THE POWERGLIDE WAS PLACED AND THE CLINICIAN FLUSHED THE LINE, SHE NOTICED THAT THERE WAS LEAKING WHERE THE CATHETER AND HUB MEET. SHE PULLED IT OUT A BIT AND FLUSHED AGAIN AND CONFIRMED THAT THERE WAS A SHEAR IN THE CATHETER. THERE WAS NO PATIENT HARM. CLINICIAN HAD TO PULL OUT THE POWERGLIDE AND PLACE ANOTHER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540098 ↗
• MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A LEAKING CATHETER WAS FOUND, WITH A HOLE LOCATED AT THE BASE NEAR THE CATHETER'S HUB, REQUIRING THE CLINICIAN TO REPLACE THE LINE. NO ADVERSE EVENT OR SERIOUS INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516167 ↗
• InjuryMar 7, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THERE WAS AN INCIDENT WITH A POWERGLIDE PRO RT. THE NURSE BROKE THE MIDLINE OFF IN A PATIENT¿S ARM. STATED THAT SHE MAY HAVE SHEARED THE CATHETER WHEN SHE TOLD THEM SHE ADVANCED THE GUIDEWIRE AND THEN ADVANCED THE CATHETER AND HIT RESISTANCE HALFWAY, SO SHE THEN PULLED THE WINGS BACK AND TRIED TO RE-ADVANCE AND THEN COULDN¿T REMOVE THE DEVICE. WHEN SHE WAS ABLE TO PULL BACK ON THE DEVICE WITH SOME MANIPULATION AND HALF THE CATHETER CAME OUT. THE OTHER HALF OF THE CATHETER WAS IN THE PATIENT¿S ARM. DOCTOR WAS CALLED AND WAS ABLE TO COME AND REMOVE THE DEVICE AT BEDSIDE. STATED THE EXTRA CATHETER WAS NOT IN THE VEIN AND WAS IN TISSUE. CUSTOMER STATES THAT THEY EDUCATED HER ON WHY THIS HAPPENED AND NOT RE-ADVANCING THE CATHETER. PATIENT HAD TO HAVE THE CATHETER REMOVED FROM ARM. ADDITIONAL INFORMATION RECEIVED 02/15/2024: IT WAS REPORTED NO PATIENT INJURY. EVENT RESULTED IN A DELAY OR CHANGE OF TREATMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18862506 ↗
• InjuryJun 22, 2023Break; Break

  IT WAS REPORTED THAT POWERGLIDE (PG) CAME APART IN PATIENT'S ARM. PG LOCATED IN PATIENT'S ARM. PATIENT GOING TO SURGERY IN THE MORNING FOR REMOVAL. ADDITIONAL INFO RECEIVED 6/6/2023: IT WAS REPORTED BY THE CUSTOMER "PATIENT HAD TO GO TO SURGERY TO REMOVE CATHETER. ALL PIECES WERE REMOVED AND ACCOUNTED FOR."

  Patient problems: Foreign Body In Patient

  MAUDE report 17187278 ↗
• InjurySep 15, 2022Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "THE RN WAS PLACING THE DEVICE WITH THIS COMPANY REP AT BEDSIDE. PATIENT GOT ACCESS, WALKED HER NEEDLE IN, INSTAFLASH CONFIRMED, GUIDEWIRE WAS ADVANCED WITH NO ISSUE, CATHETER THEN ADVANCED AND PATIENT REPORTED PAIN, RN WHO WAS PLACING REPORTED NO RESISTANCE BUT I ENCOURAGED RN TO STOP AND NOT ADVANCE CATHETER ANYMORE. I THEN INSTRUCTED THE RN TO SLOWLY PULL BACK ON THE ENTIRE SYSTEM WHICH SHE DID BUT AT THAT TIME THE PATIENT JERKED THEIR ARM CAUSING THE CATHETER TO MOVE. RN REPORTED THAT "THE CATHETER MOVED". I THEN INSTRUCTED THE RN TO PICK UP THE ULTRASOUND PROBE AND PLACE IT OVER THE SITE TO SEE WHERE THE CATHETER TIP WAS AT THAT TIME. DIFFICULTY FINDING THE NEEDLE TIP AT FIRST BUT IT APPEARED THAT THE NEEDLE TIP WAS NEXT TO THE VESSEL (IN SOFT TISSUE). RN REPORTED DIFFICULTY PULLING BACK ON THE DEVICE SO I INSTRUCTED HER TO STOP AT THE TIME, I THEN STEPPED OUTSIDE THE PATIENTS ROOM AND CALLED PICC RN TO HELP COME ASSIST DUE TO THE PLACER RN BEING A TRAINEE. ONCE PICC RN ARRIVED SHE ATTEMPTED TO SLOWLY REMOVE THE DEVICE BUT FELT RESISTANCE, RN LOCATED NEEDLE TIP USING ULTRASOUND PROBE AND ALSO NOTED THAT THE TIP OF THE CATHETER AND GUIDEWIRE TO BE IN THE SOFT TI

  Patient problems: Pain

  MAUDE report 15434950 ↗
• MalfunctionOct 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "WHEN ATTEMPTING TO REMOVE ENTIRE POWERGLIDE FROM PATIENT, NEEDLE SHEARED CATHETER AND UNABLE TO BACK OUT DEVICE STILL ACTIVE. CONSULTED WITH VASCULAR INTERVENTIONAL RADIOLOGY AND CALLED POWERGLIDE MANUFACTURER FOR TROUBLESHOOTING STEP. I WAS ABLE TO DISENGAGE THE NEEDLE AND GUIDEWIRE AND REMOVE THEM. IN DOING THAT THE REMAINDER OF THE CATHETER, BROKEN BUT STILL IN ONE PIECE, WERE EASILY REMOVED FROM THE PATIENT'S SKIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685097 ↗
• InjuryJul 22, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "INSERTED MIDLINE. ENCOUNTERED SOME DIFFICULTY IN THREADING CATH COMPLETELY IN, BUT TROUBLE SHOOTING WITH THE 10CC NS FLUSH ALLOWED GOOD BLOOD FLOW AND EVENTUALLY THREADED COMPLETELY IN (ALSO WITH GOOD BLOOD FLOW AND FLUSHING AT THAT POINT). AS DEVICE WAS REMOVED FROM SKIN, NOTED THAT ONLY 1/3" OF THE GUIDE WIRE WAS EXPOSED ON THE END OF DEVICE (NORMALLY 1" IS EXPOSED). RADIOLOGY WORK AREA INFORMED AND HUMERUS X-RAY ORDERED. RESIDENT ORDERED CHEST X-RAY. CT CHEST-NEG FOR FB".

  Patient problems: Foreign Body In Patient

  MAUDE report 12214424 ↗
• MalfunctionJun 4, 2021Activation Problem; Activation Problem

  IT WAS REPORTED WHEN MIDLINE NEEDLE WAS RETRACTED FROM ARM THE SAFETY STAYED IN THE PLUG AND THE NEEDLE WAS LEFT EXPOSED. ADDITIONAL INFORMATION RECEIVED 05/18/2021 VIA PHONE CALL "WE PLACED THE MIDLINE AND WHEN WE ADVANCED THE CATHETER COMPLETELY IN AND WHEN WE RETRACTED THE NEEDLE, THE SAFETY PORTION STAYED WITH THE PLUG AND THE NEEDLE CAME OUT INDEPENDENTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939652 ↗
• MalfunctionSep 23, 2020Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDWATCH "SAFETY DEVICE ON CATHETER WOULD NOT ENGAGE AND ON ATTEMPT TO REMOVE THE NEEDLE AND GUIDEWIRE RESISTANCE WAS MET".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574764 ↗
• MalfunctionSep 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POWERGLIDE HAS A TINY PINHOLE UP WHERE THE HUB CONNECTS ONTO THE CATHETER. IT WAS OBSERVED WHEN THE LINE WAS PLACED AND WHEN IT WAS FLUSHED, IT SQUIRTED AT THE NURSE. 8/28/2019: ADDITIONAL INFORMATION: NURSE HAD TO RE-STICK THE PATIENT TO INSERT A NEW DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082859 ↗