Peripheral Catheter Insertion Kit F120080Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741110528), received between Nov 22, 2016 and Dec 23, 2020 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2020Break; Material Separation; Improper or Incorrect Procedure or Method; Material Perforation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method

  IT WAS REPORTED 3CM DISTAL END OF GUIDEWIRE RETAINED IN PATIENT UPON ABORTED INSERTION ATTEMPT. RESISTANCE TO REMOVAL WAS NOTED BY INSERTER PRIOR TO BREAK. ALSO NOTED WAS A PERFORATION IN THE CATHETER, CATHETER WAS COMPLETELY REMOVED HOWEVER, THOUGH WIRE BROKE OFF. WIRE WAS RETRIEVED BY INTERVENTIONAL RADIOLOGY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11068438 ↗
• InjurySep 10, 2020Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "A 1CM SECTION OF THE CATHETER SHEERED OFF DURING INSERTION." "ON (B)(6) 2020, I ATTEMPTED A VERY DIFFICULT PLACEMENT OF A 20G 8CM POWERGLIDE PRO (LOT # REDW0537) INTO A TORTUOUS RIGHT CEPHALIC VEIN. THE VESSEL STARTED AT ABOUT 0.5CM DEEP. I INSERTED THE NEEDLE APPROXIMATELY 2CM, THREADED THE GUIDEWIRE, FOLLOWED BY THE CATHETER. THE CATHETER WOULD NOT ADVANCE MORE THAN APPROXIMATELY 4CM. I PULLED BACK THE DEVICE INCLUDING CATHETER, GUIDEWIRE, AND NEEDLE AND MET RESISTANCE. THE HOUSING AND GUIDEWIRE CONTINUED OUT EASILY, LEAVING THE CATHETER BEHIND WITH A VISIBLE SHEAR CLOSE TO THE END OF THE CATHETER. I ATTEMPTED TO GRAB THE DISTAL PORTION OF THE CATHETER WITH STERILE HEMOSTATS AND GENTLY REMOVE. THE DISTAL AND PROXIMAL PORTIONS OF THE CATHETER SEPARATED WITH MINIMAL EFFORT. THE REMOVED CATHETER MEASURED 7CM WITH A JAGGED EDGE. THIS INCIDENT OCCURRED IN THE MICU, AND I CALLED THE CRITICAL CARE MD TO THE BEDSIDE, WHO ASSESSED WITH ULTRASOUND AND FOUND WHAT HE SUSPECTED TO BE ARTIFACT CAUSED BY THE CATHETER IN THE SUBCUTANEOUS TISSUE PROXIMAL TO MY INSERTION SITE. A STAT CT OF THE RIGHT UPPER EXTREMITY W/ IV CONTRAST AND CHEST CT ANGIOGRAM PULMONARY EMBOLI PROTOCOL W/

  Patient problems: Foreign Body In Patient

  MAUDE report 10518006 ↗
• MalfunctionApr 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "POWERGLIDE PLACEMENT WAS SUCCESSFUL IN RIGHT UPPER ARM. IV THEN INFILTRATED DURING ANTIBIOTIC THERAPY."

  Patient problems: Infiltration into Tissue

  MAUDE report 9916123 ↗
• InjuryApr 1, 2020Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED "WE HAVE HAD AN ISSUE WITH ONE OF OUR POWERGLIDE PRO DEVICES TODAY. IT WAS INSERTED PER NORMAL TECHNIQUE AND WHEN THE WAS WITHDRAWN IT WAS NOTED THAT ABOUT 2 CM OF THE PLASTIC SHEATH WAS MISSING. THE MD ORDERED AN XRAY OF THE PT AND WE NOTED THAT THE SHEATH WAS STILL IN THE PT¿S ARM. PT IS FINE. NO PROBLEMS AT ALL BUT THIS IS VERY WEIRD OCCURRENCE. THE NURSE PERFORMING THE PROCEDURE HAS BEEN PLACING ADVANCED LINES SINCE 2015. WE PULLED 4-5 MORE DEVICES AND ATTEMPTED TO RECREATE THIS INCIDENT AND IT WAS ABSOLUTELY IMPOSSIBLE AS THE SHEATH IS SUPER FLEXIBLE AND STRETCHES WHEN PULLED AND WE WERE UNABLE TO BREAK IT." 3/12/2020 - ADDITIONAL INFORMATION RECEIVED: THE COMPLAINANT REPORTED THAT SURGEONS WERE CONSULTED AND IT WAS DETERMINED TO LEAVE THE RETAINED CATHETER SEGMENT IN PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9913804 ↗
• InjuryOct 31, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, "POWERGLIDE WAS PLACED WITH OBSERVATION FROM AN EXPERIENCED LINES TEAM MEMBER. PATIENT WAS IN THE ICU AND HAD MULTIPLE SPASMS WHICH WOULD CAUSE HIM TO JERK SPORADICALLY. THE LINE WAS BEING PLACED WITH THE PATIENT HAVING MULTIPLE JERKING MOMENTS, THE WIRE THREADED FINE, BUT THEY MET RESISTANCE WITH THE CATHETER. THEY PULLED BACK ON THE CATHETER WHICH WE ARE ASSUMING MAY HAVE BEEN PERFORATED BY THE NEEDLE. THEY THEN PULLED THE ENTIRE DEVICE TOGETHER WITHOUT MUCH FORCE AND THAT¿S WHEN THEY NOTICED APPROX. 2 CM¿S MISSING FROM THE CATHETER TIP. THEY IMMEDIATELY CALLED FOR ULTRASOUND WHICH SHOWED THE TIP IN THE TISSUE VS. THE VEIN. A DR. DETERMINED IT IS BETTER TO LEAVE IT SINCE IT IS IN THE TISSUE AND WILL NOT MIGRATE. NO FURTHER INTERVENTION WAS NECESSARY. PATIENT IS STILL IN THE HOSPITAL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261948 ↗
• InjuryJun 6, 2018Break

  IT WAS REPORTED THAT THE MIDLINE CATHETER WAS PLACED IN CEPHALIC VEIN OF RIGHT UPPER ARM. IT WAS STATED THAT THE WIRE WAS ADVANCED WITHOUT ANY RESISTANCE, BUT ONCE CATHETER WAS ADVANCED, RESISTANCE WAS MET. THE CLINICIAN PROCEEDED TO RETRACT WIRE AND THEN CATHETER AT WHICH POINT THE PATIENT EXPRESSED DISCOMFORT. ONCE HE REMOVED THE DEVICE, THE PLACER NOTED THAT THE TIP OF THE CATHETER HAD BEEN SHEARED OFF. VASCULAR SURGEON STATED HE WAS CONTEMPLATING THE NEED TO SURGICALLY REMOVE THE BROKEN CATHETER. ON (B)(6) 2018- ADDITIONAL INFORMATION RECEIVED STATED THE VASCULAR SURGEON DECIDED AGAINST OPERATING ON THE PATIENT. HE WAS CONCERNED ABOUT DOING AN EXPLORATORY SURGERY WHICH MAY SUBJECT THE PATIENT TO A HIGHER RISK OF INFECTION AND FELT LIKE THE PATIENT COULD WAIT ON HAVING THE SURGERY.

  Patient problems: Discomfort

  MAUDE report 7576175 ↗
• MalfunctionMay 23, 2018Bent; Kinked

  IT WAS REPORTED THAT PATIENT HAD A POWERGLIDE MIDLINE PLACED IN 2018 AFTER 11PM WITH ULTRASOUND. IT WAS STATED THE POWERGLIDE WAS CHECKED AT 8AM THE NEXT MORNING AND "A SOFTBALL SIZE" INFILTRATE WAS FOUND, AND THERE WAS NO BLOOD RETURN. THE MIDLINE WAS REMOVED AND APPEARED BENT AND KINKED 1/2-1CM FROM THE HUB.

  Patient problems: Infiltration into Tissue

  MAUDE report 7539226 ↗
• InjuryMay 23, 2018Break; Difficult to Remove; Device Slipped

  IT WAS REPORTED THAT GUIDE WIRE ADVANCED FINE, BUT THE CATHETER SLIPPED OUT OF THE BOTTOM OF THE HOUSING WHEN PUSHED FORWARD. IT WAS STATED THAT WHEN THE CLINICIAN NOTICED THIS, HE PULLED THE DEVICE OUT, AND THE GUIDEWIRE AND THE CATHETER HAD SHEARED. THE CLINICIAN WAS ABLE TO RETRIEVE THE GUIDEWIRE AS IT WAS STILL VISIBLE OUTSIDE THE SKIN, HOWEVER THE BROKEN PIECE OF THE CATHETER REMAINED IN THE PATIENT. THE CATHETER WAS RETRIEVED IN THE IR BY CUTTING A 4 INCH INCISION IN THE PATIENTS ARM.

  Patient problems: No Code Available

  MAUDE report 7539207 ↗
• MalfunctionMar 29, 2018Fluid/Blood Leak

  THE FACILITY REPORTED TO THE SALES REP THAT THE PATIENT WENT TO CT FOR CT WITH CONTRAST. IT WAS STATED CT TECH ATTEMPTED TO GIVE CONTRAST, HAD PROBLEM GETTING CONTRAST IN, ATTEMPTED AGAIN, THEN NURSE NOTICED BLOOD DRIPPING FROM IV. THE DRESSING REMOVED AND IT WAS REPORTED THAT BLOOD WAS DRIPPING FROM CATHETER NEAR INSERTION SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383938 ↗
• InjurySep 15, 2017Break; Physical Resistance

  PER MEDWATCH REPORT, THE FACILITY REPORTED THAT 1 CM PORTION OF MIDLINE CATHETER SHEARED OFF AFTER ENCOUNTERING RESISTANCE DURING PLACEMENT. IT WAS STATED THE PATIENT REQUIRED MINOR SURGERY UNDER LOCAL ANESTHESIA TO REMOVE RETAINED CATHETER PORTION.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6869239 ↗
• InjuryAug 31, 2017Detachment Of Device Component; Material Fragmentation; Difficult to Remove

  IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP THAT THE VASCULAR ACCESS NURSE WAS UNABLE TO FULLY THREAD THE POWERGLIDE. WHEN REMOVING THE DEVICE, THE FULL CATHETER DID NOT COME OUT. THE PATIENT WAS SENT TO ULTRASOUND, WHERE THE OTHER HALF OF THE CATHETER WAS OBSERVED LAYING IN BETWEEN TWO VALVES IN THE BASILIC VESSEL. THE RETAINED CATHETER WAS REMOVED BY A SURGEON A FEW DAYS LATER. THE PT. DID NOT EXHIBIT ANY SYMPTOMS DURING THE OCCURRENCE. I CANNOT ANSWER WHAT HAPPENED BEFORE OR AFTER RETAINED CATHETER REMOVED BECAUSE I WAS NOT HERE WHEN IT WAS REMOVED DAYS LATER AFTER OCCURRENCE. NOT SURE, GUIDE WIRE ADVANCED WITH EASE AND CATHETER ADVANCED EASILY 50% WHEN A BUCKLING/KINK NOTED UNDER SKIN AT INSERTION SITE. I HAD NO TROUBLE RETRACTING CATHETER BACK TO STRAIGHTEN IT. I NOTICED HALF OF CATHETER MISSING. A TUNNELED PICC WAS PLACED BY IR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835570 ↗
• MalfunctionAug 31, 2017Disconnection

  FACILITY REPORTED TO THE SALES REP THAT DURING PLACEMENT OF THE POWERGLIDE PRO THE CATHETER AND THE WIRE BECAME SEVERED/DISCONNECTED. THE WIRE AND THE CATHETER WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS STOPPED. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835163 ↗
• MalfunctionJun 27, 2017Break; Detachment Of Device Component; Difficult to Remove; Physical Resistance

  PER SALES REP, THE FACILITY REPORTED THE NURSE WAS PLACING POWER GLIDE PRO AND FELT RESISTANCE. THE RN TRIED TO PULL BACK ON DEVICE, FELT RESISTANCE, AND SAW SKIN MOVEMENT AROUND INSERTION SITE DUE TO THE RESISTANCE. IT WAS STATED THE RN DID NOT WANT TO FORCE THE DEVICE REMOVAL WITH ADDED PRESSURE SO THE RN ADVANCE THE CATHETER SLIGHTLY AND WAS SUCCESSFUL IN REMOVING THE DEVICE. ONCE THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE WIRE HAD BROKEN OFF THE DEVICE AND WAS INSIDE THE CATHETER. THE RN MEASURED THE WIRE AGAINST ANOTHER NEW DEVICE AND IT WAS REPORTEDLY INTACT WITHOUT ANY PART OF THE WIRE REMAINING INSIDE THE PATIENT. AN X-RAY ORDER WAS PLACED AND A PHYSICIAN WAS CONSULTED TO ENSURE PATIENT SAFETY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672342 ↗
• MalfunctionJun 8, 2017Difficult to Remove; Failure to Advance

  FACILITY REPORTED TO THE SALES REP THAT THE HEALTHCARE PROFESSIONAL WAS NOT ABLE TO ADVANCE THE CATHETER AND HAD DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT'S ARM. THE NEEDLE AND THE CATHETER WERE REMOVED INTACT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6623950 ↗
• InjuryMay 23, 2017Break; Detachment Of Device Component

  PER SALES REP, THE FACILITY REPORTED THAT DURING PLACEMENT OF THE POWERGLIDE THE WIRE BROKE OFF AND REMAINED IN THE PATIENTS SUBCUTANEOUS TISSUE. IT WAS STATED THAT THE WIRE WAS REMOVED IN IR AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6584611 ↗
• InjuryFeb 22, 2017Difficult to Remove

  PER MEDWATCH FORM, THE FACILITY REPORTED THAT THEY PLACED A POWERGLIDE MIDLINE CATHETER WITH THE SELDINGER TECHNIQUE. UPON PULLING THE WIRE BACK TO REMOVE IT, THERE WAS RESISTANCE FELT. THE HEALTHCARE PROFESSIONAL (HCP) REMOVED THE CATHETER ITSELF TO SEE IF THAT WOULD HELP PULL THE WIRE OUT BUT THE WIRE WOULD NOT COME OUT OF THE PATIENT'S ARM. ULTRASOUND INDICATED THAT THE WIRE WAS OUTSIDE THE VEIN. AN X-RAY WAS DONE AND SHOWED THE WIRE INSIDE THE ARM. PATIENT WAS TAKEN TO RADIOLOGY FOR REMOVAL. IT WAS REPORTED THAT THE WIRE WAS UNRAVELED UPON REMOVAL.

  Patient problems: No Code Available

  MAUDE report 6350779 ↗
• MalfunctionNov 22, 2016Break

  11/04/2016- PER SALES REPRESENTATIVE, THE FACILITY REPORTED A SHEARED CATHETER. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6120648 ↗