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STATLOCK IV0500Recalls & reported problems

Bard Access Systems, Inc. · SL IV ULTRA PEDS · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741081750), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 21, 2019Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE PACKAGING. THE DEVICE WAS NOT USED A PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8722099 ↗

Other DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices

All DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.