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Bard Poly Midline CK000107ARecalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2

All models of Bard Poly Midline (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741182693), received between Jul 8, 2021 and Dec 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Device problems

  • Material Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionDec 16, 2021Material Deformation; Material Deformation

    IT WAS REPORTED A FAULTY DILATOR. ADD INFO RCVD: PLACED LINE WITH FAULTY DILATOR. USED DILATOR FROM A SEPARATE KIT TO COMPLETE LINE PLACEMENT. WAS THERE PATIENT HARM REPORTED?: NO. (B)(6) 2021: THE RETURNED SAMPLE EXHIBITED A DEFORMED SHEATH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13018400 ↗
  • MalfunctionJul 8, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THE WIRES BEING FLIMSY AND DULL CAUSING PROBLEMS WITH INSERTIONS. THE WIRES ARE NOT THREADING PROPERLY, KINKING AND LOOPING ON THEMSELVES. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12135017 ↗

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

All Catheter, intravascular, therapeutic, long-term greater than 30 days devices →

Sources and updates

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