Peripheral Catheter Insertion Kit AC0181250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741110900), received between Jun 14, 2018 and Oct 5, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Backflow; Backflow

  IT WAS REPORTED AN 18G ¿ 1.25IN INTRAVASCULAR CATHETER HAS INTERMITTENT ISSUES WITH THE BLOOD CONTROL VALVE, EACH TIME WE WOULD RETRACT THE NEEDLE, THE CATHETER WOULD HAVE INSTANT BLOOD FLOW BEFORE CONNECTING THE LUER-LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580706 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "LAST WEEK, UPON RETRACTING THE NEEDLE, A PLASTIC PIECE CAME OUT WITH THE END OF THE WIRE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580704 ↗
• InjuryFeb 6, 2020Material Frayed; Material Frayed

  IT WAS REPORTED VIA RECEIVED MEDWATCH " PATIENT HAD RETAINED GUIDE WIRE IN THE RIGHT FOREARM AFTER INSERTION OF THE IV". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9679565 ↗
• InjuryDec 21, 2018Break

  IT WAS REPORTED THAT WHEN PLACING AN 18G 1.25 INCH ACCUCATH CATHETER WITH ULTRASOUND GUIDANCE, THE BLOOD RETURN WAS GOOD, BUT THE GUIDEWIRE WOULD NOT THREAD. THE GUIDEWIRE WAS RETRACTED AND REPOSITIONED SEVERAL TIMES AND EVENTUALLY THREAD THROUGH FOR A SUCCESSFUL IV PLACEMENT. IT WAS OBSERVED THAT THE TIP OF THE GUIDEWIRE APPEARED TO BE ALTERED AFTER REMOVAL AND A RIGHT ARM X-RAY WAS ORDERED. IT WAS STATED THE PATIENT WAS TAKEN TO SURGERY AND THE IV WAS USED WITHOUT ANY PROBLEMS. THE RADIOLOGIST STATED THERE WAS A THIN LINE ON THE X-RAY, BUT COULD NOT CONFIRM IF IT WAS A PIECE OF WIRE OR NOT. THE IR NP STATED THAT IT WAS TOO SMALL TO RETRIEVE IF IT IS WIRE AND THE IV WAS REMOVED WITHOUT INCIDENT. IT WAS REPORTED THAT THE AREA WAS WITHOUT ANY SWELLING, REDNESS, OR TENDERNESS. THE WIRE COULD NOT BE PALPATED AND THE PATIENT WAS DISCHARGED WITHOUT ANY APPARENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 8189465 ↗
• InjurySep 13, 2018Break

  IT WAS REPORTED THE TIP OF A GUIDEWIRE BROKE OFF INSIDE A PATIENTS FOREARM. IT WAS STATED THAT THE TIP OF GUIDEWIRE REMAINS IN PATIENTS SUBCUTANEOUS TISSUE. ON 08/31/2018 ADDITIONAL DETAILS RECEIVED BY COMPLAINANT: "PLACING ACCESS TO REMOVE SWAN. INITIAL ATTEMPTS BY OTHER RN SUGGESTED SCLEROTIC VEINS. LARGE COMPRESSIBLE VEIN AT DEPTH OF 0.5-1CM IN PTS L FA WAS IDENTIFIED FOR USE. GUIDEWIRE WAS PROPERLY RETRACTED AND APPROPRIATE PROCEDURE FOLLOWED. VEIN IDENTIFIED BY US. UPON INSERTION, RN NOTED VERY THICK SKIN. VISUALIZED ACCESS OF VESSEL, ADVANCED NEEDLE FURTHER USING STEPPING METHOD TO ENSURE PROPER DEPTH TO BE ABLE TO ADVANCE CATHETER. ADVANCED GUIDEWIRE ABOUT 1.5¿ AND MET RESISTANCE, RETRACTED GUIDEWIRE AND MET RESISTANCE AT ABOUT 1CM TO FULLY RETRACTED POSITION BUT ABLE TO FULLY RETRACT. AT THIS POINT VESSEL INTEGRITY QUESTIONED: VEIN WAS PRESENT BUT POSSIBLY ALTERED. RN ADVANCED NEEDLE FURTHER USING STEPPING METHOD AND REATTEMPTED TO ADVANCED GUIDEWIRE MEETING RESISTANCE AGAIN AT 1.5¿ AND AGAIN AT 1CM TO FULLY RETRACTED POSITION. ABLE TO FULLY RETRACT. ADVANCED CATHETER, DEPRESSED NEEDLE LOCKING MECHANISM, AND WITHDREW GUIDEWIRE TO ASSESS BLOOD RETURN (WHICH THERE WAS NONE).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7873824 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component; Failure to Advance

  IT WAS REPORTED THE THAT DURING PLACEMENT THE RN STUCK THE PATIENT AND COULDN¿T SEE HER NEEDLE TIP AFTER LOOKING FOR A WHILE. IT WAS STATED THE RN FOUND A SHADOW OF THE NEEDLE TIP AND IT WOULDN¿T PIERCE THE VESSEL EASILY AND SHE FELT LIKE IT POPPED IN. THE RN TRIED TO ADVANCE THE WIRE BUT IT WOULDN¿T GO (IT WORKED PRIOR TO INSERTION). IT WAS REPORTED THE ACCUCATH WOULDN¿T SAFETY AND WAS PULLED IT OUT. IT WAS NOTED THAT THE NEEDLE WAS TURNED SIDEWAYS AND IT WOULD NOT SAFETY AND THE WIRE WOULD NOT ADVANCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602585 ↗