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Medline Industries, Inc. DYNJ38849DRecalls & reported problems

Medline Industries, Inc. · BASIN SET KIT · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942966998), received between Jan 22, 2019 and Feb 14, 2019 — classified as 1 injury, 1 malfunction.

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

Device problems

  • Material Separation2

Patient problems

  • Foreign Body In Patient1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 14, 2019Material Separation

    IT WAS REPORTED THAT DURING AN UNIDENTIFIED PROCEDURE, GAUZE MATERIAL WAS IDENTIFIED IN THE SURGICAL SITE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8341323 ↗
  • InjuryJan 22, 2019Material Separation

    DURING A HYDROCELECTOMY/SPERMATOCELECTOMY, THE SURGEON WAS USING A RAYTEC SPONGE, IT SHREDDED AND A LONG PIECE SEPARATED FROM THE SPONGE AND WAS FOUND LATER IN THE WOUND. REMOVED BEFORE CLOSURE.

    Patient problems: Foreign Body In Patient

    MAUDE report 8270892 ↗

Other General surgery tray devices

All General surgery tray devices →

Sources and updates

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