Peripheral Catheter Insertion Kit F318108PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741140662), received between Mar 6, 2018 and Apr 14, 2026 — classified as 14 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (16 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Break

  IT WAS REPORTED THAT THE POWERGLIDE CATHETER SHEARED AND DISLODGED INTO PATIENT DURING INSERTION. PATIENT NEEDED TO HAVE IT SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24872528 ↗
• MalfunctionApr 6, 2026Activation Problem

  IT WAS REPORTED THAT THE CLEAR PIECE THAT COVERS THE NEEDLE FOR SAFETY CAME OFF. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION: NO NEEDLESTICK INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795147 ↗
• MalfunctionDec 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THE POWERGLIDE DID NOT SAFETY THE NEEDLE, THE ¿BARREL¿ CHAMBER REMAINED IN THE PRODUCT HOUSING, NO WIRE EVIDENT FROM NEEDLE TIP, BELIEVE IT REMAINED IN THE HOUSING. NO NEGATIVE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716522 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDSUN PATIENT RECEIVED A MIDLINE FOR HOME ANTIBIOTICS AND RIGHT BEFORE DISCHARGE, MIDLINE INFILTRATED. NO IDENTIFIED SKIN INJURY AND ENTIRE CATHETER WAS REMOVED. A NEW ONE WAS PLACED AND NO ADDITIONAL INTERVENTION WAS REQUIRED.

  Patient problems: Infiltration into Tissue

  MAUDE report 22906557 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem

  PT RECEIVED A MIDLINE FOR HOME ANTIBIOTICS AND RIGHT BEFORE DISCHARGE, MIDLINE INFILTRATED.

  Patient problems: Infiltration into Tissue

  MAUDE report 22792158 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED POWERGLIDE CATHETER SEPARATED FROM HUB. CUSTOMER MENTIONED THAT THEY SUSPECT A NURSE CUT THE CATHETER ON ACCIDENT AND THAT IT WASN'T PRODUCT RELATED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635933 ↗
• InjuryFeb 26, 2025Break; Break

  IT WAS REPORTED BY MEDWATCH POWERGLIDE PRO MIDLINE CATHETER WAS DISCOVERED WITH THE CANNULA BROKEN AFTER INSERTING INTO A PATIENT. THE PATIENT BLED PROFUSELY AND UPON INVESTIGATION THE CANNULA WAS DISCOVERED BROKEN. THE CANNULA WAS REMOVED FROM THE PATIENT WITHOUT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21472091 ↗
• MalfunctionFeb 21, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, NEEDLE DISCONNECTED FROM POWERGLIDE HOUSING. THIS HAPPENED AFTER THREADING THE CATHETER AND TRYING TO SAFETY THE DEVICE. ADDITIONAL INFORMATION RECEIVED 30-JAN-2025: IT WAS REPORTED THE NEEDLE DID NOT SHARPS ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434583 ↗
• MalfunctionFeb 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE SEPARATED FROM THE DEVICE HANDLE DURING USE, REQUIRING MANUAL REMOVAL BY THE CLINICIAN. UPON RETRIEVAL, THE NEEDLE WAS FOUND TO HAVE EXPOSED SHARPS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421769 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT MIDLINE LEAKING OUTSIDE THE PATIENT. UPON REMOVAL, EXAMINATION THE CATHETER WAS FOUND TO BE HALF SHEARED CRACKED AT BASE. NEW DEVICE PLACED. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779860 ↗
• InjurySep 3, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER "VASCULAR REGISTERED NURSE WAS ATTEMPTING TO CANNULATE LEFT CEPHALIC. RN MADE TWO ATTEMPTS TO ADVANCE/THREAD CATHETER, CANNULATION WAS UNSUCCESSFUL. UPON RETRACTION/REMOVAL OF POWERGLIDE IT WAS NOTED PART OF THE CATHETER WAS FRACTURED, APPROXIMATELY 3 CM WAS MISSING. UPPER ARM CEPHALIC WAS IMMEDIATELY ASSESSED. PART OF THE CATHETER WAS NOTED/SEEN IN UPPER ARM CEPHALIC. ADDITIONAL INFORMATION RECEIVED 8/19/2024: IT WAS REPORTED THAT ON (B)(6) 2024 WHEN THE RN WAS ATTEMPTING TO PLACE THE CATHETER, WHEN SHE REMOVED THE WIRE, SHE NOTICED A PIECE OF IT WAS MISSING. THE PATIENT REQUIRED SURGERY TO REMOVE THE FOREIGN BODY/WIRE AND IT WAS SENT TO PATHOLOGY. ULTRASOUND USED TO CONFIRM THAT ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO NEGATIVE IMPACT OR OTHER HARM REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20129668 ↗
• InjuryJul 20, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH, AN ATTEMPT WAS MADE TO PLACE AN 18G POWERGLIDE MIDLINE TO THE PATIENT¿S RIGHT CEPHALIC. ADHERING TO STERILE TECHNIQUE, THE 18G CATHETER WAS GUIDED INTO THE CENTER OF THE RIGHT CEPHALIC VEIN USING ULTRASOUND GUIDANCE. THE GUIDEWIRE WAS ADVANCED BUT WAS UNABLE TO ADVANCE THE CATHETER WITHOUT RESISTANCE. THE CATHETER WAS RETRACTED, THEN THE GUIDEWIRE. WHEN THE CANNULA WAS RENDERED SAFE BY LOCKING THE NEEDLE, IT APPEARED TO BE MISSING 1CM OF THE CATHETER TIP. ULTRASOUND REVEALED WHAT APPEARED TO BE THE CATHETER TIP IN OR NEAR THE CEPHALIC VEIN. PHYSICIAN WAS IMMEDIATELY NOTIFIED, AND A RUE ULTRASOUND WAS ORDERED. VASCULAR ACCESS RN WAS ALSO NOTIFIED. PATIENT REPORTED NO PAIN OR DISCOMFORT AT THE INSERTION SITE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19787346 ↗
• MalfunctionJul 10, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY BROKE. NO ONE WAS HARMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712129 ↗
• InjuryJun 18, 2024Break; Break

  IT WAS REPORTED, WHEN NURSE STUCK FOR THE ACCUCATH, HE WAS UNABLE TO ADVANCE THE CATHLON, SO HE RETRACTED THE NEEDLE, AND WAS TRYING TO REMOVE THE CATHLON AND GUIDEWIRE BUT WAS HAVING DIFFICULTY. DURING THIS THE GUIDEWIRE BROKE WITH HALF OF IT STILL IN THE PATIENT¿S ARM. HE WAS ABLE TO GRAB THE GUIDEWIRE AND FINALLY REMOVE THE GUIDEWIRE AND CATHLON. THEY OBTAINED AN X-RAY OF THE PATIENT¿S ARM AND FOUND PART OF THE GUIDEWIRE STILL IN THE ARM BUT ALSO IT APPEARS THAT PART OF THE MIDLINE CATHETER IS IN THE ARM. VASCULAR CONSULTED. VASCULAR REVIEWED AND NOTED THE POSSIBLE TIP OF CATHETER/ GUIDEWIRE IN TISSUE. VASCULAR DOES NOT PLAN TO REMOVE THE TIP OF THE CATHETER SINCE IN THE TISSUE AND FELT NO HARM. THE DOCTOR WAS NOTIFIED. HE HAD NO DIFFICULTY INSERTING OR REMOVING THE MIDLINE, SO WE ARE UNSURE HOW PART OF THE CATHETER REMAINED IN THE ARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19557911 ↗
• MalfunctionJun 14, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT BEDSIDE NURSE NOTICED SOME LEAKING AROUND IV SITE DURING ASSESSMENT. PICC NURSE NOTICED THAT IV CATHETER IS COMPLETELY SEVERED FROM THE HUB. MD ORDERED REMOVAL OF RETAINED CATHETER VIA INTERVENTIONAL RADIOLOGY (IR). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19536887 ↗
• MalfunctionJun 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THERE APPEARS TO BE A HOLE OR RIP IN THE CATHETER BODY JUST BELOW THE HUB OF THE POWERGLIDE. ADDITIONAL INFORMATION RECEIVED 05/15/2024: ROUTINE DRESSING CHANGE PERFORMED ON MIDLINE. WHEN ATTEMPTING TO ASPIRATE BLOOD WITH THE DRESSING REMOVED, IT WAS NOTED THAT AUR WAS PULLING INTO THE SYRINGE. WHEN FLUSH WAS ATTEMPTED, SALINE WAS LEAKING OUT OF THE CATHETER JUST ABOVE THE CONNECTION OF THE CATHETER HUB. VAT RN REMOVED THE MIDLINE AND ASSESSED IT, IDENTIFYING A DISRUPTION IN THE CATHETER. INSERTING RN STATED THE INSERTION WAS STANDARD AND THERE WERE NO COMPLICATIONS. LEAK OCCURRED DURING DRESSING CHANGE, NOTHING OBSERVED PRIOR. NO HARM IDENTIFIED. PATIENT DID NOT REQUIRE REPLACEMENT OF MIDLINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484858 ↗
• MalfunctionJun 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT EXTENSION SETS IN THE POWERGLIDE PRO KITS LEAKING JUST UNDER THE CONNECTION SITE. EXTENSION SET CHANGED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 05/21/2024: THERE WAS NO PATIENT HARM, AS THE ISSUE WAS CAUGHT BEFORE STARTING THE LINE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446858 ↗
• InjuryMay 3, 2024Break; Break

  IT WAS REPORTED THAT THE PIECE BROKE OFF IN PATIENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 04/25/2024: IT WAS REPORTED, ¿THIS WAS AN UNSUCCESSFUL ATTEMPT AND WHEN REMOVING THE CATHETER ABOUT 1CM WAS MISSING OFF THE TIP OF THE POWERGLIDE PRO. THE TIP WAS CONFIRMED LEFT IN THE SUB Q TISSUE. PATIENT TO BE FOLLOWED BY SURGERY TO WATCH SITE. NO INTERVENTION NEEDED AT THIS TIME. THE TIP REMAINS IN PATIENT PER PHYSICIAN AND PATIENT DECISION.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 19240280 ↗
• MalfunctionMay 1, 2024Activation Problem; Activation Problem

  IT WAS REPORTED, "DEFECTIVE POWERGLIDE DEVICE. DEVICE INSERTION WAS EASY AND SMOOTH. AFTER REMOVAL OF THE NEEDLE AND MAIN PG HOUSING, THE NEEDLE SHIELD AND GUIDEWIRE WERE NOT PRESENT ON THE REMOVED MAIN DEVICE THAT YOU WOULD NORMALLY EXPECT TO SEE. NURSE IS EXPERIENCED PG PLACER. INITIAL FEAR WAS THAT THE GUIDEWIRE MAY HAVE BEEN LEFT IN PATIENT SOMEHOW. X-RAY WAS ORDERED AND NO GUIDEWIRE FOREIGN OBJECT WAS FOUND. DOCTOR ORDERED THE POWERGLIDE TO BE REMOVED AND REPLACED WITH A NEW ONE, WHICH THE NURSE DID SUCCESSFULLY. ASSUMPTION IS THAT THE DEVICE WAS LIKELY DEFECTIVE AND DID NOT INCLUDE THE NEEDLESHIELD AND GUIDEWIRE BEFORE THE INSERTION BEGAN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222886 ↗
• MalfunctionApr 25, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT SAFETY MALFUNCTION ON THE POWERGLIDE. RISK OF NEEDLE STICK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188667 ↗
• MalfunctionApr 24, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "BEDSIDE NURSE NOTICED SOME LEAKING AROUND IV SITE DURING ASSESSMENT, NOTIFIED THIS ANM AND INSTRUCTED REGISTERED NURSE (RN) TO CALL MIDLINE/PICC NURSE. PICC NURSE NOTICED THAT IV CATHETER IS COMPLETELY SEVERED FROM THE HUB. DOCTOR AND HOUSE SUPERVISOR WERE NOTIFIED IMMEDIATELY. MD ORDERED REMOVAL OF RETAINED CATHETER VIA INTERVENTIONAL RADIOLOGY (IR)."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169996 ↗
• InjuryApr 4, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT, "THE CATHETER WAS CRIMPED/SERRATED INDICATING POSSIBLE SEVERANCE OF THE CATHETER. OB RN INITIALLY REPORTED EDEMA, ERYTHEMA, AND HARDNESS ALONG BASILIC VEIN PATH BOTH PROXIMAL AND DISTAL TO INSERTION SITE WITH CONCERN FOR BOTH CLOT AND PHLEBITIS. VAT RN ASSESSED SITE WITH ULTRASOUND AND FOUND A NON-OCCLUSIVE CLOT IN BASILIC VEIN EXTENDING TO CONNECTION WITH BRACHIAL VEIN. WITHIN THE CLOT JUST DISTAL TO THE BRACHIAL VEIN WAS A SMALL WHITE LUMINESCENT CIRCULAR IMAGE. WRITER RETRIEVED REMOVED CATHETER AND NOTED THE VERY END (1-2MM) WAS CRIMPED/SERRATED INDICATING POSSIBLE SEVERANCE OF THE CATHETER. REMOVED CATHETER COMPARED TO ANOTHER 18 G 10 CM BARD POWERGLIDE. DESPITE THE MIDLINES BEING DIFFERENT LOT NUMBERS, THE REMOVED CATHETER'S TIP WAS SLIGHTLY SHORTER COMPARED TO THE UNUSED CATHETER. A DIAGNOSTIC VENOUS ULTRASOUND WAS PERFORMED TO ASSESS THE RUE AND THE ULTRASOUND TECH ALSO NOTED THE SAME SMALL WHITE LUMINESCENT CIRCULAR IMAGE POTENTIALLY CONSISTENT WITH A FOREIGN BODY WITHIN THE BODY OF THE NON-OCCLUSIVE CLOT." ADDITIONAL INFORMATION RECEIVED 25 MARCH 2024: THE PATIENT HAD A THROMBOSIS AT THE TIP OF CATHETER THAT RESULTED IN A FURTHER THROMBOSI

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus; Vasculitis

  MAUDE report 19041808 ↗
• MalfunctionJan 9, 2024Material Frayed; Defective Component; Material Frayed; Defective Component

  IT WAS REPORTED SWAT RN PLACING PG MIDLINE TO PATIENTS LEFT FA WITH US ASSIST. AFTER LINE PLACED - GUIDE WIRE DID NOT APPEAR TO BE IN THE ANTICIPATED PLACE IN THE ASSIST DEVICE PER RN. MD NOTIFIED IMMEDIATELY - MD AT BEDSIDE. XRAY OF CHEST AND ARM ORDERED AND COMPLETED. MD DISCUSSED SITUATION AND RESULTS WITH RADIOLOGIST. LINE OK'D TO USE PER MD AT THIS TIME. IVOS STARTED FOR POTENTIALLY INEFFECTIVE PIECE OF EQUIPMENT. NO ADVERSE OUTCOMES NOTED AT TIME OF PLACEMENT OR POST PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480773 ↗
• MalfunctionDec 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A POWERGLIDE WAS RETURNED FOR EVALUATION WITHOUT A REPORTED COMPLAINT. INITIAL OBSERVATION REVEALED THIS DEVICE HAS THE NEEDLE DETACHED FROM THE HOUSING AND THE GUIDEWIRE IS STILL INSIDE HOLDING THE TWO PIECES TOGETHER. 11/29/2023 - DURING EVALUATION, THE NEEDLE WAS FOUND TO HAVE FULLY SEPARATED FROM THE GREEN NEEDLE HUB WITHIN THE HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 18249862 ↗
• MalfunctionNov 22, 2023Activation Problem; Activation Problem

  DURING INVESTIGATION OF THE RETURNED DEVICE, ENGINEER REPORTED THE SAFETY MECHANISM HAD SEPARATED FROM THE NEEDLE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194956 ↗