PowerGlide Midline Catheter M120101Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741038075), received between Apr 22, 2016 and Feb 13, 2019 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2019Leak/Splash; Material Separation

  IT WAS REPORTED THAT EXTENSION SET CAME APART AT CONNECTION BETWEEN LUER DEVICE AND TUBING ON THE POWERGLIDE, CAUSING BLOOD LEAKAGE. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337792 ↗
• MalfunctionFeb 13, 2019Break; Fluid/Blood Leak

  IT WAS REPORTED THAT EXTENSION SET CAME APART AT CONNECTION BETWEEN LUER DEVICE AND TUBING ON THE POWERGLIDE, CAUSING BLOOD LEAKAGE. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337775 ↗
• MalfunctionFeb 13, 2019Leak/Splash; Material Separation

  IT WAS REPORTED THAT EXTENSION SET CAME APART AT CONNECTION BETWEEN LUER DEVICE AND TUBING ON THE POWERGLIDE, CAUSING BLOOD LEAKAGE. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337773 ↗
• MalfunctionFeb 13, 2019Leak/Splash; Material Separation

  IT WAS REPORTED THAT EXTENSION SET CAME APART AT CONNECTION BETWEEN LUER DEVICE AND TUBING ON THE POWERGLIDE, CAUSING BLOOD LEAKAGE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337772 ↗
• MalfunctionFeb 13, 2019Break

  IT WAS REPORTED THAT EXTENSION SET CAME APART AT CONNECTION BETWEEN LUER DEVICE AND TUBING ON THE POWERGLIDE, CAUSING BLOOD LEAKAGE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8337771 ↗
• MalfunctionDec 21, 2018Leak/Splash

  IT WAS REPORTED THAT THE EXTENSION TUBING INCLUDED IN THE POWERGLIDE KIT BEGAN TO LEAK FROM BETWEEN THE HUB CONNECTION AND EXTENSION SET POST-INSERTION(PLACEMENT). IT WAS STATED THAT THIS HAPPENED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Information

  MAUDE report 8189693 ↗
• MalfunctionDec 21, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING INCLUDED IN THE POWERGLIDE KIT BEGAN TO LEAK FROM BETWEEN THE HUB CONNECTION AND EXTENSION SET POST-INSERTION(PLACEMENT). IT WAS STATED THAT THIS HAPPENED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8189397 ↗
• InjuryJan 10, 2017Break; Physical Resistance

  NURSE REPORTED THAT THEY INSERTED A MIDLINE INTO A PATIENT AND HAD SOME PROBLEMS WITH THE CATHETER. THE NURSE STATED THAT THEY ENTERED THE VEIN, RECEIVED BLOOD RETURN AND THEN ADVANCED THE GUIDEWIRE WITHOUT ISSUE. THE NURSE THEN BEGAN ADVANCING THE ANGIO AND ABOUT A COUPLE OF INCHES IN THE PLASTIC CARTRIDGE THAT HOLDS THE DEVICE, IT OPENED UP COMPLETELY. AT THAT TIME THE NURSE WAS UNABLE TO ADVANCE THE ANGIO FORWARD OR BACKWARD. THEY THEN DECIDED TO PULL THE NEEDLE OUT AND FELT RESISTANCE. THE PATIENT¿S ARM WAS REPOSITIONED AND THE NURSE WAS ABLE TO WITHDRAW THE NEEDLE WITH RESISTANCE. NURSE REPORTED THAT WHEN INSPECTING THE NEEDLE, IT LOOKED LIKE THERE WAS ABOUT ONE INCH OF GUIDE WIRE ON ¿TOP¿. THE ANGIO WAS NOT FULLY INSPECTED BECAUSE THE NEEDLE WAS IN THE ANGIO. THE PATIENT¿S PRIMARY DOCTOR WAS CONTACTED TO ADVISE ON CONCERNS WITH REMOVING THE CATHETER AND WITH ORDERING AN X-RAY OF THE RIGHT ARM TO CHECK FOR FOREIGN BODY. AN X-RAY WAS DONE AND CAME BACK NEGATIVE. THE PATIENT LATER STATED THAT THEY FELT LIKE THERE WAS A SPLINTER IN THEIR ARM. A NURSE INSPECTED AND WAS ABLE TO REMOVE APPROXIMATELY TWO INCHES OF ANGIO FROM THE PATIENT¿S ARM. THE CATHETER WAS REMOVED AND THERE WAS N

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6239397 ↗
• InjuryApr 22, 2016Material Fragmentation; Failure to Advance

  ON (B)(6) 2016 - PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT A PICC NURSE WAS PLACING A 10CM POWERGLIDE IN THE RIGHT BASILICA VEIN USING ULTRASOUND GUIDANCE. THE WIRE INSERTED SMOOTHLY BUT WOULD NOT ADVANCE ENTIRELY TO THE END WHERE IT LOCKS. THE NURSE ADVANCED THE CATHETER AND THE CATHETER REPORTEDLY ALSO FAILED TO ADVANCE ALL THE WAY. THE NURSE USED THE PROBE TO SCAN THE ARM AND IT WAS SAID HE THOUGHT HE SAW A BIFURCATION AND ASSUMED THAT'S WHY THE WIRE AND CATHETER WOULD NOT ADVANCE. HE REMOVED THE ENTIRE DEVICE AS ONE UNIT AND SAID HE FELT NOTHING UNUSUAL AND THAT IT CAME OUT SMOOTHLY. THE SITE WAS BLEEDING SO HE APPLIED PRESSURE WITH GAUZE. WHEN THE NURSE LOOKED AT THE POWERGLIDE, THE NEEDLE WAS EXTENDED BEYOND THE CATHETER AND A PORTION OF THE CATHETER WAS MISSING. HE PICKED THE PROBE BACK UP AND SCANNED THE ARM AND SAW THE CATHETER WAS STILL IN THE VEIN. HE MEASURED THE REMAINING CATHETER ON THE STERILE FIELD AND DETERMINED THAT THERE WAS ABOUT 2.75CM MISSING, LEFT IN THE PATIENT'S VEIN. A SURGEON PERFORMED A CUT-DOWN TO REMOVE THE CATHETER. NO OTHER HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 5600410 ↗