Peripheral Catheter Insertion Kit F118101Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741110566), received between Sep 13, 2016 and Jun 29, 2022 — classified as 4 injuries, 23 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2022Break; Break

  IT WAS REPORTED "A NURSE WAS HAVING DIFFICULTY ADVANCING THE POWERGLIDE PRO, SHE REMOVED IT AND RETRIED AND ENCOUNTERED THE SAME ISSUES. SHE STATES WHEN SHE WAS TRYING TO REMOVE THE CATHETER, IT BROKE OFF IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 14854093 ↗
• MalfunctionOct 6, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "DURING POWERGLIDE PLACEMENT CATHETER DEPLOYED FINE BUT RESISTANCE WAS FELT WHILE PULLING BACK TO ACTIVATE SAFETY. UPON REMOVAL OF NEEDLE IT WAS OBSERVED THAT THE WIRE APPEARED TO BE SHORT AND HAD SHEARED OFF. AFTER FURTHER INSPECTION OF THE DEVICE (REMOVING HOUSING TO PULL WIRE OUT AND COMPARE WIRE LENGTHS), IT BECAME CLEAR THAT THE SAFETY DID NOT PROPERLY DEPLOY AND WAS SITTING IN FRONT OF THE NEEDLE GIVING THE APPEARANCE OF A SHORTENED WIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12582967 ↗
• MalfunctionAug 25, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "GUIDEWIRE FROM POWERGLIDE PRO. AFTER UNSUCCESSFUL INSERTION AND DEPLOYMENT OF GUIDEWIRE, PROCEDURE ABORTED AS CATHETER COULD NOT BE ADVANCED, WHEN REMOVED, THE GUIDEWIRE WAS FOUND TO BE BENT AND ELONGATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368425 ↗
• MalfunctionAug 18, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "MIDLINE CATHETER DEFECTIVE. WHEN ATTEMPTED TO USE AND ADVANCE WHEN IN VESSEL THE GUIDEWIRE WOULD NOT WORK CORRECTLY." IT WAS STATED THAT UPON REMOVAL GUIDEWIRE WAS EXTREMELY THIN AND LONG "WHICH IS NOT CORRECT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340406 ↗
• InjuryMay 25, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "I WAS COACHING A NEW VASCULAR ACCESS RN THROUGH A POWERGLIDE PRO INSERTION WITH USE OF A SITE-RITE 8. RN BELIEVED HE WAS IN THE VESSEL, AND ADVANCED THE GUIDEWIRE. I ASKED IF HE FELT RESISTANCE AS HE ADVANCED THE GUIDEWIRE. HE STATED NO, SO I TOLD HIM HE COULD ADVANCE THE CATHETER. THE CATHETER ADVANCED PARTLY, BUT THE RN WAS GETTING RESISTANCE. I TOLD HIM TO PULL OUT, BUT HE INSTEAD BEGAN TO RETRACT THE CATHETER BACK OVER THE NEEDLE. I TOLD HIM TO STOP AND PULL THE ENTIRE DEVICE OUT. AFTER THE DEVICE WAS RETRACTED, I INSPECTED IT, AND NOTICED A PORTION OF THE CATHETER WAS LEFT IN THE PATIENT." PATIENT IMPACT: "THE CATHETER SHEARED WHEN HE RETRACTED THE CATHETER OVER THE NEEDLE, AND ROUGHLY AN INCH OF THE DISTAL END OF THE CATHETER REMAINED IN THE PATIENT. THE TOURNIQUET WAS LEFT ON, AND I NOTIFIED THE PATIENT'S RN. I ASKED HER TO CONTACT THE PATIENT'S PRIMARY DOCTOR. AN X-RAY WAS ORDERED, AND THE REMAINING PORTION OF THE CATHETER WAS LOCATED IN THE TISSUE OF THE PATIENT, AND WAS NOT IN THE PATIENT'S VASCULAR SYSTEM. THE PRIMARY RN TOLD ME IT WOULD JUST BE A FOREIGN BODY REMOVAL LIKE A SPLINTER. THEY WERE PLANNING TO MAKE A SMALL INCISION, AND REMOVE THE CATHETER."

  Patient problems: Foreign Body In Patient

  MAUDE report 11881616 ↗
• InjuryJan 4, 2021Break; Physical Resistance/Sticking

  IT WAS REPORTED "NURSES ATTEMPTED PLACE CATHETER AND SUCCESSFULLY PLACED IN THE VESSEL AND THREW HER WIRE AND PARTIALLY ADVANCED CATHETER AND MET RESISTANCE. PULLED BACK CATHETER SMOOTHLY AND THEN TRIED TO PULL BACK WIRE AND HAD RESISTANCE DURING PULL BACK AND THEN A PORTION OF THE CATHETER BROKE OFF IN THE PATIENTS VEIN. PATIENT HAD TO GO TO SURGERY TO REMOVE OBJECT. OCCURRED ON (B)(6), 4 TO 5CM OF WIRE LEFT IN PATIENT AND CONFIRMED IN VEIN BY CARDIOVASCULAR PHYSICIAN." ADD INFO RCVD 12/15/2020: CUSTOMER ATTEMPTED TO PLACE THE POWERGLIDE PRO RT CATHETER AND THE A PORTION OF THE GUIDEWIRE BROKE DURING AN ATTEMPT TO RETRACT THE CATHETER BACK TO PULL OUT CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 11109200 ↗
• MalfunctionMay 14, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED PER RECEIVED MEDWATCH "MET EXCESSIVE RESISTANCE WHILE INSERTING THE POWERGLIDE CAUSING THE PATIENT INCREASED PAIN. RESISTANCE FELT DURING INSERTION WAS NOT NORMAL AND WAS EXCESSIVE. THE INSERTION WAS COMPLETED AND THE CATHETER REMAINED PATENT IN THE PATIENT."

  Patient problems: Pain

  MAUDE report 10055681 ↗
• MalfunctionApr 8, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS MORE RESISTANCE THAN NORMAL UPON INSERTIONS, CAUSING VERBALIZED PAIN TO THE PATIENT, AND HAD A DISTINCT POP AS IT PASSED THROUGH THE SKIN.

  Patient problems: Pain

  MAUDE report 9937669 ↗
• MalfunctionApr 8, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WAS MORE RESISTANCE THAN NORMAL UPON INSERTIONS, CAUSING VERBALIZED PAIN TO THE PATIENT, AND HAD A DISTINCT POP AS IT PASSED THROUGH THE SKIN.

  Patient problems: Pain

  MAUDE report 9937636 ↗
• MalfunctionApr 2, 2020Defective Component; Defective Component

  IT WAS REPORTED 3 PICC NURSES HAD THE SAME EXPERIENCE WITH THE SAME LOT NUMBER/DEVICE. ALL 3 NURSES ARE NOTING THEY ARE ABLE TO ACCESS THE VEIN AND THREAD THE GUIDEWIRE BUT THE CATHETER WILL NOT DEPLOY AND BUNCHES UP UNDER THE SKIN. THIS REPORT ADDRESSES THE FIRST OF THREE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916929 ↗
• MalfunctionApr 2, 2020Defective Component; Defective Component

  IT WAS REPORTED 3 PICC NURSES HAD THE SAME EXPERIENCE WITH THE SAME LOT NUMBER/DEVICE. ALL 3 NURSES ARE NOTING THEY ARE ABLE TO ACCESS THE VEIN AND THREAD THE GUIDEWIRE BUT THE CATHETER WILL NOT DEPLOY AND BUNCHES UP UNDER THE SKIN. THIS REPORT ADDRESSES THE THIRD OF THREE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916928 ↗
• MalfunctionApr 2, 2020Defective Component; Defective Component

  IT WAS REPORTED 3 PICC NURSES HAD THE SAME EXPERIENCE WITH THE SAME LOT NUMBER/ DEVICE. ALL 3 NURSES ARE NOTING THEY ARE ABLE TO ACCESS THE VEIN AND THREAD THE GUIDEWIRE BUT THE CATHETER WILL NOT DEPLOY AND BUNCHES UP UNDER THE SKIN. THIS REPORT ADDRESSES THE SECOND OF THREE DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916926 ↗
• MalfunctionMar 18, 2020Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED THAT DURING PLACEMENT THE POWERGLIDE CATHETER WAS DIFFICULT TO ADVANCE, AND THE RN HAD TO HAD TO "POP IT IN". IT WAS STATED THE INSERTION WAS UNSUCCESSFUL AND THE RN HAD TO RE-STICK THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849121 ↗
• MalfunctionMay 15, 2018Disassembly; Looping; Malposition of Device

  IT WAS REPORTED THAT THE NURSE PLACED THE POWERGLIDE CATHETER AND UPON REMOVAL OF THE PLASTIC CASING THERE WAS NO GUIDEWIRE EXTERNAL OF THE SAFETY. COMPLETED SCANS WERE REPORTED TO SHOW NO GUIDEWIRE LEFT INSIDE THE PATIENT. IT WAS STATED RISK ASSESSMENT DISSEMBLED THE PLASTIC CASING AND DETERMINED THE WIRE WAS INTACT, BUT ALLEGEDLY LOOPED IN THE PLASTIC CASING AND HAD RETRACTED THROUGH THE SAFETY NEEDLE AREA. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516918 ↗
• MalfunctionMar 12, 2018Retraction Problem

  IT WAS REPORTED THAT THE POWERGLIDE WAND WAS USED TO ACCESS THE LEFT BASILICA VEIN WITH THE NEEDLE. THE RN ATTEMPTED TO PULL THE WIRE BACK, BUT IT WOULD NOT RETRACT BACK INTO THE WAND. IT WAS STATED CATHETER ADVANCED EASILY, BUT THE LAST 1 CM WOULD NOT ADVANCE. THE RN REMOVED THE WAND EASILY FROM THE CATHETER AND PULLED CATHETER BACK VERY SLOWLY AS THERE WAS NO BLOOD RETURN. IT WAS REPORTED THE RN DECIDED TO ABORT, BUT THE LAST 1 CM OF THE CATHETER WOULD NOT COME OUT OF THE VEIN. PHYSICIAN WAS CALLED TO THE PATIENT'S BEDSIDE, THE ARM WAS WARM PACKED AND PHYSICIAN REMOVED THE CATHETER INTACT AND NOTICED THE WIRE REMAINED IN THE CATHETER. PICC RN RETRIEVED THE WAND FROM THE TRASH AND NOTICED THE WIRE WAS MISSING FROM THE WAND. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7333045 ↗
• MalfunctionNov 16, 2017Retraction Problem; Failure to Advance; Physical Resistance

  PER SALES REP, THE FACILITY REPORTED THE RN FIRST ATTEMPTED INSERTION IN THE LEFT BASILIC VEIN AND WAS NOT SUCCESSFUL. THE SECOND ATTEMPT WAS IN THE LEFT BRACHIAL VEIN, AND THE RN WAS ABLE TO CANNULATE, (ABLE TO VISUALIZE NEEDLE IN USG). THE RN ATTEMPTED TO ADVANCE THE GUIDEWIRE FOLLOWED BY THE CATHETER, BUT MET RESISTANCE TO THREAD IT IN. IT WAS STATED THAT THE RN TRIED TO RETRACT THE ENTIRE UNIT, HOWEVER WAS UNSUCCESSFUL. A WARM COMPRESS AND TOURNIQUET WAS APPLIED AND THEY WAITED FOR 5 MINUTES THEN REMOVAL WAS RE-ATTEMPTED. THE RN WAS THEN ABLE TO PULL THE WHOLE UNIT OUT WITHOUT RESISTANCE. THE DOCTOR WAS AT THE BEDSIDE AND THE RN EXPLAINED THE SITUATION, THE DOCTOR SUGGESTED AN X-RAY OF THE LEFT ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7039798 ↗
• MalfunctionSep 15, 2017Malposition of Device

  PER MEDWATCH REPORT, THE FACILITY REPORTED USER WAS PLACING MIDLINE IN THE PATIENT'S LEFT UPPER ARM AND INSERTED THE GUIDEWIRE ON THE POWERGLIDE NEEDLE. IT WAS STATED WHEN THE USER PULLED OUT, THE GUIDEWIRE WAS NOT ON THE NEEDLE. APPROXIMATELY 1CM OF THE GUIDEWIRE WAS OUT OF THE PUNCTURE SITE. THE USER PULLED THE GUIDEWIRE OUT AND APPLIED PRESSURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6870758 ↗
• MalfunctionJul 14, 2017Device Operates Differently Than Expected

  FACILITY REPORTED TO THE SALES REP THAT THE DEVICE WAS PLACED AND THE NEEDLE WAS "SAFETIED". THE HEALTHCARE PROFESSIONAL (HCP) STATED THE GUIDEWIRE WAS NOT VISIBLE, CONCERNED THAT THE GUIDEWIRE BROKE OFF IN THE PATIENT. PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY AND WAS UNABLE TO LOCATE THE WIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6715673 ↗
• MalfunctionJun 23, 2017Break; Fluid/Blood Leak; Noise, Audible

  PER SALES REP, THE FACILITY REPORTED THAT TWO NURSE ASSISTANTS WERE HELPING TO PUT A BRIEF ON THE PATIENT AND REPOSITION THE PATIENT IN BED. THE PATIENT WAS INSTRUCTED TO PUT HER ARMS ON HER CHEST. THE IV PUMP WITH EXTENSION TUBING WAS ATTACHED TO THE EXTENSION SET OF THE MIDLINE AND THE TUBING AND PUMP WERE ON THE SAME SIDE AS THE MIDLINE. IT WAS STATED THERE WAS ENOUGH SLACK IN THE IV TUBING TO REPOSITION THE PATIENT. IT WAS REPORTED THAT AN AUDIBLE SNAP LIKE BREAKING PLASTIC WAS HEARD BY THE NURSE ASSISTANT AND THE PATIENT. THE FACILITY SAID NEITHER OF THEM COULD FIGURE OUT WHAT THE SNAP WAS UNTIL THE MAGNESIUM WHICH WAS INFUSING VIA THE MIDLINE BEGAN TO COME OUT OF THE BROKEN EXTENSION SET ONTO THE NURSE ASSISTANT¿S PANTS WHICH BECAME WET WITH MEDICATION. THE NURSE ASSISTANT CALLED THE NURSE WHO CLAMPED THE MIDLINE AND ATTACHED A NEW EXTENSION SET. THE MIDLINE DRESSING ALSO HAD TO BE CHANGED AND THE MANIPULATION OF THE CATHETER LED TO THE MIDLINE NO LONGER WORKING. THIS WAS THE PATIENT'S ONLY ACCESS AND IT WAS EXPRESSED THAT SHE WAS EXTREMELY DIFFICULT SHE COULD NOT RECEIVE HER MEDICATIONS OVERNIGHT. FACILITY REPORTED THE PATIENT WAS UNHARMED IN THIS EVENT. 6/9/2017-ADDITIONAL

  Patient problems: Chemical Exposure

  MAUDE report 6663578 ↗
• MalfunctionMay 19, 2017Coiled

  AS REPORTED BY THE FACILITY TO THE TM, "IV NURSE RETRACTED DEVICE AFTER BEING UNABLE TO THREAD CATHETER. THE GUIDEWIRE WAS NOT VISIBLE ON THE END OF THE DEVICE. IT WAS FOUND COILED IN THE BACK OF THE DEVICE HOUSING. THIS MAY HAVE HAPPENED AFTER THE GUIDEWIRE WAS DEPLOYED ONCE AND DID NOT ADVANCE INTO THE VEIN AND WAS RETRACTED. THE NEEDLE WAS REDIRECTED AND THEN THE GUIDEWIRE DEPLOYED FOR THE SECOND TIME. IT IS UNKNOWN IF THE GUIDEWIRE DID INDEED DEPLOYED A SECOND TIME AS THE DEVICE NEEDLE WAS STILL IN THE PATIENT AFTER BEING REDIRECTED. " NOTE FROM SALES REPRESENTATIVE: THE PRODUCT HAS BEEN DISMANTLED SINCE WE NEEDED TO MAKE SURE THE GUIDEWIRE WAS ALL IN TACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6577993 ↗
• MalfunctionMay 4, 2017Difficult to Remove; Sticking

  IT WAS REPORTED BY THE FACILITY THAT THE IV STATLOCK WAS EXCESSIVELY STICKY AND VERY DIFFICULT TO REMOVE RESULTING IN PATIENT SKIN TEAR.

  Patient problems: Skin Tears

  MAUDE report 6543489 ↗
• MalfunctionMar 30, 2017Component Falling; Activation, Positioning or Separation Problem; Device Operates Differently Than Expected

  PER CLINICAL SPECIALIST THE RN AT THE FACILITY REPORTED HE PULLED THE WIRE BACK, WENT TO STICK AND COULDN'T GET THE NEEDLE IN THE SKIN, THEN CHECKED AND THE WIRE WAS SLIGHTLY DEPLOYED. THE RN STATED THAT HE TRIED TO PULL THE WIRE BACK AND IT "FELL INSIDE" THE DEVICE. THIS FILE ADDRESS THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446595 ↗
• MalfunctionMar 30, 2017Disassembly; Failure to Cut

  PER CLINICAL SPECIALIST THE RN AT THE FACILITY REPORTED HE PULLED THE WIRE BACK, WENT TO STICK AND COULDN'T GET THE NEEDLE IN THE SKIN, THEN CHECKED AND THE WIRE WAS SLIGHTLY DEPLOYED. THE RN STATED THAT HE TRIED TO PULL THE WIRE BACK AND IT "FELL INSIDE" THE DEVICE. THIS FILE ADDRESS THE INITIAL DEVICE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6446582 ↗
• MalfunctionMar 22, 2017Material Protrusion/Extrusion

  FACILITY REPORTED THAT WHILE EXTRACTING THE GUIDEWIRE AFTER INSERTION THE STAFF NOTICED A FINE PIECE OF GUIDEWIRE EXTRUDING FROM THE OPEN END OF THE MIDLINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425452 ↗
• InjuryJan 12, 2017Material Fragmentation

  PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT THE DEVICE "MALFUNCTIONED". IT WAS STATED THAT DURING PLACEMENT THE CATHETER SHEARED AND BECAME STUCK IN THE PATIENT'S TISSUE. THE CATHETER FRAGMENT WAS LEFT IN THE PATIENT'S TISSUE. NO LONG-TERM OR PERMANENT IMPAIRMENT TO THE PATIENT WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6248283 ↗