BARD Poly Midline CK000400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741096198), received between May 10, 2017 and Jul 5, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Knotted” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2017Knotted

  PER SALES REP, THE RN REPORTED AN "INCIDENT OF KNOT IN GUIDEWIRE".

  Patient problems: No Information

  MAUDE report 6685831 ↗
• MalfunctionMay 10, 2017Unraveled Material

  IT WAS REPORTED BY RN THAT DURING THE PROCEDURE THE GUIDEWIRE TIP "UNSPOOLED". ON 04/25/2017- ADDITIONAL INFORMATION RECEIVED FROM RN STATED, "PATIENT RETRACTED ARM WHILE THREADING GUIDE WIRE THROUGH INSERTION NEEDLE (POSSIBLE SHEAR OCCURRED) AND NITINOL WIRE TIP UNSPOOLED WHILE RETRACTING WIRE. A WIRE FRAGMENT IN TISSUE ON X-RAY OF HUMERUS. PATIENT SENT TO I.R. FOR RETRIEVAL OF WIRE FRAGMENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 6556728 ↗