Peripheral Catheter Insertion Kit F120108PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741140587), received between Mar 26, 2019 and Mar 12, 2026 — classified as 10 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE DRESSING FROM THE POWERGLIDE INSERTION KITS ARE NOT STICKING. MENTIONED QUALITY OF DRESSING. THIS IS ON ALL OF THEM. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582697 ↗
• MalfunctionFeb 26, 2026Break; Material Frayed; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT THE GUIDEWIRE DETACHED FROM THE DEVICE AND REMAINED INSIDE THE PATIENT ARM. IT WAS REPORTED THAT THE GUIDEWIRE LATER BACK TRACKED OUT OF THE PATIENT ARM AND WAS REMOVED. NO MAJOR INJURY WAS NOTED BASED ON SUBSEQUENT IMAGING, AND THE GUIDEWIRE WAS INTACT. THE CATHETER WAS INTACT AND FLUSHED WITH NO EVIDENCE OF SHEARING. STAFF REPORTED THAT THE INSERTION HAD BEEN SMOOTH, BUT WHEN THE CATHETER WAS THREADED THE PATIENT EXPERIENCED SEVERE PAIN AND THE ENTIRE DEVICE WAS REMOVED. THE STAFF DID NOT INITIALLY NOTICE THAT THE GUIDEWIRE WAS MISSING, AND IT WAS FOUND PROTRUDING FROM THE ARM APPROXIMATELY FIFTEEN MINUTES LATER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24461656 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak

  IT WAS REPORTED, HOLE NEAR HUB OF THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290997 ↗
• MalfunctionDec 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE SAFETY PART POPPED OFF WHEN WENT PULLED TO SAFETY THE DEVICE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717487 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT PAIN AFTER FLUSHING BUT NO RESISTANCE WHEN FLUSHING.

  Patient problems: Pain

  MAUDE report 22732093 ↗
• MalfunctionAug 6, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE POWERGLIDE 20G 10CM WAS VERY POSITIONAL, EXTREMELY HARD TO PUSH, PUMP IS ALWAYS BEEPING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22732063 ↗
• MalfunctionFeb 19, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING USE, THE POWER GLIDE SAFETY MECHANISM DID NOT ENGAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412845 ↗
• InjuryDec 29, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER "WE HAD AN EPIV TIP BREAK OFF INTO A PATIENT OVER THE WEEKEND. THE PLACER SAID IT HAPPENED ON INSERTION BUT NOT SURE WHEN, BUT IT WAS AN UNSUCCESSFUL INSERTION. SHE DID NOT MEET RESISTANCE WHEN ADVANCING THE WIRE. SHE SAW A THE PIECE OF THE CATHETER IN THE PATIENT'S TISSUE VIA ULTRASOUND. THE MD RECOMMENDS LEAVING OBJECT RETAINED AND THEREFORE IT IS NOT REMOVED FROM THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 21032779 ↗
• MalfunctionNov 18, 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. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716780 ↗
• MalfunctionOct 22, 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 20501474 ↗
• MalfunctionJul 25, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT POWERGLIDE NEEDLE DID NOT SAFETY WHEN REMOVED FROM THE PATIENT. NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824516 ↗
• MalfunctionApr 16, 2024Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT DURING PLACEMENT THEY NOTED AIR BEING DRAWN INTO THE SYRINGE DURING PULL BACK. CATHETER WAS REMOVED AND A SMALL HOLE WAS OBSERVED IN THE CATHETER CLOSE TO THE HUB. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121915 ↗
• MalfunctionFeb 25, 2024Activation Problem; Activation Problem

  IT WAS REPORTED, "WHEN CLINICIAN WENT TO SAFETY THE NEEDLE, THE CHAMBER THAT THE NEEDLE WOULD SAFETY IN FELL OFF." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775005 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT MIDLINE LAST NIGHT THAT FRACTURED AT THE HUB. LINE WAS PLACED AT 1239 (B)(6)23. LINE WAS NOTED TO BE LEAKING AT 2015 BY RN. FULL CATHETER WAS ABLE TO BE RETRIEVED WITHOUT FURTHER DIFFICULTY. THIS WAS A 20-10 MIDLINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909657 ↗
• MalfunctionSep 12, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT PATIENT WAS IN NEED OF IV ACCESS. MIDLINE WAS ATTEMPTED IN LEFT ARM IN THE BASILIC VEIN WITH A 20G/10CM LONG CATHETER. STERILE TECHNIQUE WAS OBTAINED. MIDLINE NEEDLE WAS INSERTED, GUIDE WIRE WAS ADVANCED. ATTEMPT TO ADVANCED CATHETER, HOWEVER PATIENT YELLED IN PAIN. PLACEMENT WAS CHECKED VIA ULTRASOUND AND IT WAS FOUND VEIN HAD RUPTURED. ALL ATTEMPTS WERE STOP, GUIDE WIRE WAS RETRACTED, CATHETER WAS RETRACTED AND MIDLINE DEVICE WAS TAKEN OUT, PRESSURE BANDAGE APPLIED. WHEN LOOKING AT DEVICE IT WAS FOUND A HALF CENTIMETER WAS MISSING. PRIMARY PHYSICIAN WAS INFORMED AND ORDERS WERE OBTAINED. PATIENTS WAS INFORMED WITH ROOM NURSE AT BESIDE. ADDITIONAL INFORMATION RECEIVED ON 28AUG2023: THE EVENT OCCURRED ON 8/22/2023. CUSTOMER DID NOT KNOW IF THE EVENT INVOLVED AN URGENT OR LIFE-THREATENING MEDICAL SITUATION. CUSTOMER CLARIFIED THAT IT WAS THE CATHETER THAT BROKE. THE BREAK WAS DISCOVERED WHEN RETRACTING FROM THE ARM AND 1/2 CM OF CATHETER WAS MISSING. THIS EVENT DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY IN TREATMENT. PATIENT HAD NO SYMPTOMS /COMPLICATIONS. PATIENT HAD AN XRAY AND ULTRASOUND AND OUTCOME SHOWED NOTHING ON EITHER DIAGNOSTIC TESTING. T

  Patient problems: Pain; Perforation of Vessels

  MAUDE report 17729306 ↗
• InjuryJun 22, 2023Break; Break

  IT WAS REPORTED THAT CATHETER EMBOLISM TO PATIENT'S LEFT UPPER ARM, 10 CM CATHETER CAME OUT 9 CM. ADDITIONAL INFO 6/8/2023: IT WAS REPORTED ¿THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. THE PATIENT EXPERIENCED INCREASED LEVEL OF PAIN WITH INSERTION BEYOND INITIAL NEEDLE STICK. CATHETER BREAKAGE WAS RETAINED IN PATIENT'S TISSUE. DOCTORS WERE MADE AWARE, CHEST AND ARM X-RAY WERE ORDERED. TOURNIQUET WAS APPLIED ABOVE THE SITE. PATIENT REMAINED FLAT. AN RRT NURSE WAS MADE AWARE WHO CONSULTED INTENSIVIST AND IR. THE EVENT CAUSED A DELAY IN MEDICATION. PATIENT NEEDED IV ACCESS FOR NAUSEA MEDICATION. SHE WAS A DIFFICULT STICK AND WE WERE CONSULTED TO PLACE A MIDLINE FOR THIS REASON. ADDITIONAL INFORMATION RECEIVED 6/14/2023: IT WAS REPORTED BY THE CUSTOMER ¿THE RETAINED CATHETER SEGMENT WAS NOT REMOVED FROM THE PATIENT AND REMAINS IN THE LEFT UPPER ARM WHERE IT HAD BEEN INSERTED. THERE WERE NOT NOTED ISSUES WITH THE CATHETER DURING INSERTION. CATHETER WAS ONLY IN THE PATIENT FOR SEVERAL SECONDS.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 17187171 ↗
• InjuryMar 30, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT "POWERGLIDE TIP CATHETER DAMAGE- TIP BROKE OFF IN PATIENT. DEVICE WAS "LOOSE" OUT OF PACKAGE PER RN." IT WAS REPORTED BY THE CUSTOMER THAT "PT IS SUPER HARD STICK WITH DVT TO RUE AND L SUBCLAVIAN COMPLETELY OCCLUDED. HAD PIV IN R AC THAT INFILTRATED. ATTEMPTED LINE IN SMALL VEIN 6CM DISTAL TO L AC. VEIN IMMEDIATELY TIED INTO A LARGER VEIN BUT WOULDN'T HAVE HAD QUITE ENOUGH SPACE IF I STUCK WHERE IT GOT LARGER SO TRIED JUST BELOW IT. VEIN WAS APPROX 1/2 CM DEEP SO WENT IN W ALMOST A FLAT ANGLE. WAS A LITTLE OFF TO ONE SIDE SO HAD TO ADJUST ANGLE SL. LOOKED LIKE I WAS IN VEIN AND THOUGHT I HAD A LITTLE BLOOD RETURN IN CATHETER SO SLID THE GUIDEWIRE OFF. DIDN'T SEEM TO HAVE ANY RESISTANCE. WHEN I TRIED TO SLIDE OFF THE CATHETER, IT ONLY WENT ABOUT 5CM AND MET RESISTANCE. I PULLED IT BACK ONTO NEEDLE WITHOUT DIFFICULTY BUT WAS UNABLE TO DISENGAGE THE GUIDEWIRE TO PULL IT BACK. THE BUTTON WOULDN'T EVEN PUSH DOWN. SO, I SLID THE CATHETER BACK OFF AS FAR AS IT WOULD GO AND REMOVED THE HOUSING WITHOUT DIFFICULTY. NOTED THE GUIDEWIRE HAD A BEND TO IT. WAS UNABLE TO ASPIRATE ANY BLOOD SO SLOWLY REMOVED CATHETER WHILE ATTEMPTING TO ASPIRATE. NEVER GOT BLOOD RE

  Patient problems: Foreign Body In Patient

  MAUDE report 16652987 ↗
• InjuryMar 22, 2023Break; Break

  BD REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION: "NOTIFIED THIS MORNING BY THE ACCOUNT THAT A POWERGLIDE CATHETER BROKE OFF IN A PATIENTS ARM. AT THIS TIME I AM AWAITING FOR THE PICC NURSE TO CALL ME TO DESCRIBE THE EVENT. THIS NURSE WAS THE PLACER OF THE DEVICE. WAS PROVIDED A SMALL BIT OF INFORMATION FROM THE NURSE AS SHE STATED THAT AT THIS TIME THE CATHETER IS STILL IN THE PATIENTS ARM AND THE PATIENT IS REFUSING REMOVAL. AN X-RAY WAS CONFIRMED THAT THERE WAS A FOREIGN BODY IN THE LEFT CEPHALIC VEIN. BASED OF THE REMAINING CATHETER THAT WAS REMOVED FROM THE PATIENT, IT APPEARS THAT ABOUT 1.3CM IS REMAINING IN THE PATIENTS UPPER EXTREMITY. " ADDITIONAL INFORMATION RECEIVED 3/8/2023: THE CLINICIAN PROVIDED THE FOLLOWING DETAILS TO THE BD REPRESENTATIVE: RN REPORTED THAT SHE ASSESSED THE L. CEPHALIC VEIN AND A 20G WAS SUITABLE FOR THE PLACEMENT. REPORTED VESSEL WAS COMPRESSIBLE AND ABOUT 1CM DEEP. STATED WHEN SHE LAUNCHED THE GUIDEWIRE THE WIRE WENT IN SMOOTHLY AND THEN ADVANCED HER CATHETER WHICH WENT SMOOTHLY UP UNTIL ABOUT HALFWAY WHEN SHE MET SLIGHT RESISTANCE. REPORTED STOPPING THE PROCEDURE DUE TO THE RESISTANCE AND PULLED THE WIRE BACK AND THEN THE DEVICE WITHOUT DIFFI

  Patient problems: Foreign Body In Patient

  MAUDE report 16592943 ↗
• MalfunctionNov 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "POWERGLIDE RT KINKING AFTER INSERTION." ADDITIONAL INFORMATION RECEIVED 11/21/2022: I PLACED A 20G 10CM POWERGLIDE IN A LARGE UPPER ARM BRACHIAL . THE VEIN WAS 0.54CM IN DIAMETER AND 1.8CM DEEP. IT WENT IN EFFORTLESSLY, HAD A GREAT BLOOD RETURN AND THE STATLOCK WAS IN PLACE. I WAS CALLED AN HOUR LATER BY THE NURSE WHO SAID THE CATHETER WOULDN'T FLUSH. UPON ASSESSING IT, THE CATHETER WOULD NOT FLUSH. I TOOK DOWN THE DRESSING AND IT APPEARED TO BE KINKED AT THE INSERTION SITE. I STRAIGHTENED IT AND IT STILL WOULDN'T FLUSH. I DECIDED TO PULL IT AND WAS ONLY ABLE TO PULL OUT 3CMS BEFORE IT STUCK AND WOULD NOT PULL OUT ANY FURTHER. I LEFT THE CATHETER IN PLACE WITH 3CMS OUT, COVERED IT AND CALLED THE IR DOC. WE GOT AN XRAY OF THE ARM AND IT WAS CLEARLY KINKED. IR CAME TO THE BEDSIDE IN THE AM. THEY WERE ABLE TO PULL IT THE REST OF THE WAY OUT AT BEDSIDE. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK PRO WAS THERE ANY PATIENT HARM REPORTED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826037 ↗
• MalfunctionNov 4, 2022Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT CATHETER WAS SHEARED AND GUIDEWIRE WAS BENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15738217 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER VIA SALES REP " I WAS CONTACTED TODAY ABOUT A POSSIBLE ¿SHEARING¿ OF A CATHETER". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15587186 ↗
• MalfunctionJul 29, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED " END POPPED OFF ACTUAL LOOP". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136253 ↗
• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED VIA MEDWATCH "PATIENT RECEIVED AN ULTRASOUND GUIDED MIDLINE IV CATHETER TO UNDERGO A NUCLEAR MEDICINE STRESS TEST. IV WAS PLACED IN THE RIGHT BASILIC VEIN WITHOUT COMPLICATION. BLOOD RETURN WITHOUT COAXING WAS OBSERVED. RADIOACTIVE TRACER AND SALINE FLUSH WAS COMPLETED. UPON COMPLETION OF THE PROCEDURE, THE CATHETER WAS ADVANCED OUT WITHOUT RESISTANCE; HOWEVER, ONLY 1 CM OF TUBING WAS REMOVED. THE OTHER 9CM OF CATHETER TUBING HAD SERVED OFF INSIDE THE PATIENT'S VEIN. SUBSEQUENT IMAGING IDENTIFIED THAT A 6.5CM CATHETER FRAGMENT HAD MIGRATED WITHIN THE RIGHT DESCENDING PULMONARY ARTERY EXTENDING INTO A SEGMENTAL BRANCH OF THE RIGHT LOWER LOBE PULMONARY ARTERY."

  Patient problems: Foreign Body In Patient

  MAUDE report 14462090 ↗
• InjuryApr 15, 2022Break; Break

  IT WAS REPORTED "PLACED ON FIRST STICK. EASY ACCESS. DC' D WITHOUT RESISTANCE." IT WAS REPORTED "WENT IN LIKE BUTTER THAT WHEN IT WAS PULLED ONLY 2CM CAME OUT. DR TRYING TO SEND THIS GUY TO OLY FOR A "CUT DOWN". APPEARS CATHETER IS STILL IN BASILIC." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: A DETAILED DESCRIPTION OF THE EVENT: POWERGLIDE PRO RT 20GAX10CM WAS PLACED WITH ULTRASOUND GUIDANCE, LOT # REFY1503, REF # F120108PT, EXP DATE, 01-31-2023. IT WAS PLACED IN ONE ATTEMPT WITH SUCCESSFUL BLOOD RETURN, AND WAS TOLERATED WITHOUT DISCOMFORT. UPON REMOVAL, THERE WAS NO RESISTANCE. 1.5 CM OF THE CATHETER ATTACHED TO THE HUB WAS PRESENT. INTERVENTIONS AND PRECAUTIONS WERE TAKEN AND IMAGING DEMONSTRATED APPROXIMATELY 6 CM OF RETAINED CATHETER. THE PATIENT WAS SCHEDULED FOR REMOVAL OF THE CATHETER AT ANOTHER FACILITY. HOW WAS THE BREAK AND/OR RETAINED SEGMENT DISCOVERED? IT WAS DISCOVERED UPON ATTEMPTED REMOVAL OF THE DEVICE. WERE ALL THE MISSING/BROKEN PIECES RETRIEVED AND ACCOUNTED FOR? SEE ABOVE. DID THE PATIENT REQUIRE SURGERY TO REMOVE THE BROKEN PIECE? THE PATIENT WAS SCHEDULED FOR A PROCEDURE AT ANOTHER FACILITY TO HAVE THE BROKEN TUBING REMOVED. WHAT TYPE OF CATHETER SECURE

  Patient problems: Foreign Body In Patient

  MAUDE report 14117963 ↗
• InjuryApr 4, 2022Migration or Expulsion of Device; Detachment of Device or Device Component

  PATIENT RECEIVED AN ULTRASOUND GUIDED MIDLINE IV CATHETER TO UNDERGO A NUCLEAR MEDICINE STRESS TEST. IV WAS PLACED IN THE RIGHT BASILIC VEIN WITHOUT COMPLICATION. BLOOD RETURN WITHOUT COAXING WAS OBSERVED. RADIOACTIVE TRACER AND SALINE FLUSH WAS COMPLETED. UPON COMPLETION OF THE PROCEDURE, THE CATHETER WAS ADVANCED OUT WITHOUT RESISTANCE; HOWEVER, ONLY 1 CM OF TUBING WAS REMOVED. THE OTHER 9 CM OF CATHETER TUBING HAD SEVERED OFF INSIDE THE PATIENT'S VEIN. SUBSEQUENT IMAGING IDENTIFIED THAT A 6.5 CM CATHETER FRAGMENT HAD MIGRATED WITHIN THE RIGHT DESCENDING PULMONARY ARTERY EXTENDING INTO A SEGMENTAL BRANCH OF THE RIGHT LOWER LOBE PULMONARY ARTERY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14014616 ↗