Midline Catheter Kit S4153108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741153938), received between Jun 22, 2023 and Apr 26, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT A GUIDEWIRE FAILURE/BREAKAGE THAT OCCURRED THIS WEEK. REF: (B)(4), LOT: REHY1089. ALL COMPONENTS WERE SAFELY REMOVED FROM THE PATIENT INTACT BUT BROKEN. IT APPEARS TO BE MORE OF AN UNWINDING OF THE ATRAUMATIC TIP AFTER POSSIBLY BE SEVERED OR SHEARED FROM CONTACT WITH THE NEEDLE TIP. NO ADVERSE MEDICAL EVENTS OR SERIOUS INJURY AS A RESULT OF THIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19198756 ↗
• MalfunctionJan 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE INTRODUCER SCRUNCHED UP AS IT WAS INSERTED THRU THE SKIN. THIS MALFUNCTION WAS NOT NOTED AS I ATTEMPTED TO INSERT INTO THE PATIENT'S VEIN, WHEN HE YELLED IN PAIN, I WITHDREW IT AND THEN NOTED THE PROBLEM. RN HAD TO USE A NEW INTRODUCER TO CONTINUE THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 18427283 ↗
• MalfunctionJun 22, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT FELT RESISTANCE WHEN PLACING MIDLINE AND WENT TO RETRACT WIRE AND NEEDLE SIMULTANEOUSLY. WHEN WIRE WAS RETRACTED, THEY NOTICED WIRE WAS UNRAVELED AT THE END. WIRE WAS RETRIEVED AND PATIENT HAD TO BE STUCK AGAIN. ADDITIONAL INFO RECEIVED ON 07-JUNE-23 : PATIENT HAS A HISTORY OF ALCOHOL ABUSE AND DIABETES. NO URGENT/LIFE THREATENING SITUATION EVENT DISCOVERED WHEN WITHDRAWING THE GUIDEWIRE. THE WIRE DID NOT BREAK BUT DID UNRAVEL. NO PIECES WERE RETAINED IN THE PATIENT. A CHEST, CLAVICLE AND ARM XRAY WAS OBTAINED. PATIENT DID NO EXPERIENCE ANY SYMPTOMS, COMPLICATIONS OR NEGATIVE OUTCOMES. ADDITIONAL INFORMATION RECEIVED 6/8: WIRE UNRAVELED APPROXIMATELY 15-20CM FROM THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187496 ↗