Peripheral Catheter Insertion Kit ST018101DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741139390), received between Oct 24, 2019 and Jun 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 17, 2020Terminated

   Iincorrectly packaged without the required lidocaine as labeled

   Z-1946-2020 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026

  IN THE PROCESS OF PLACING A BARD POWERGLIDE MIDLINE, A MALFUNCTION OCCURED. THE CATHETER IS DESIGNED TO BE INSERTED OVER A WIRE. SEVERAL ATTEMPTS TO THREAD THE CATHETER OVER THE WIRE WERE UNSUCCESSFUL. A SECOND FULL STERILE KIT NEEDED TO BE OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373795 ↗
• MalfunctionMar 17, 2026Difficult to Insert

  IT WAS REPORTED THEY TRIED TO INSERT THE CATHETER BUT IT WAS DEFECTIVE, THEY EVEN TRIED WETTING IT BUT IT WOULDN'T GO. IT WAS ROUGH. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616935 ↗
• MalfunctionOct 19, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THE SAFETY CAME RIGHT OFF OF THE INTRODUCER NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20489197 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH "MIDLINE CATHETER J-LOOP BROKE WHILE IN USE." ADDITIONAL INFORMATION RECEIVED 04/15/2024: IT WAS REPORTED BY THE CUSTOMER "NO URGENT OR LIFE-THREATENING EVENT OCCURRED DUE TO THE BREAKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229568 ↗
• MalfunctionApr 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ICU HAD A MIDLINE CATHETER J-LOOP BREAK WHILE IN USE. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 03/26/2024: IT WAS REPORTED, "I AM NOT AWARE OF ANY PATIENT IMPACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094060 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT EXTENSION SET WITHIN POWER GLIDE ST KIT BROKE WHILE IN USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072003 ↗
• MalfunctionMar 27, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH "J-LOOP PORTION ON MIDLINE CATHETER SNAPPED AND BROKE IN TWO WHEN THIS TUBING GOT CAUGHT IN THE BEDRAIL. REPLACED MIDLINE J-LOOP WITH STANDARD STOCK J-LOOP." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986809 ↗
• InjuryOct 24, 2019Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "PATIENT WITH RECENT MIDLINE CATHETER PLACEMENT ATTEMPTED. GUIDEWIRE DISLODGED AND LOCATED WITHIN THE AXILLARY VEIN EXTENDING INTO THE RIGHT ATRIUM."

  Patient problems: Foreign Body In Patient

  MAUDE report 9234333 ↗