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Safe-T TPT1005SPRecalls & reported problems

Carefusion 2200, Inc · Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403220869), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 28, 2020Terminated

    The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

    Z-2659-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Disconnection1
  • Material Separation1

Patient problems

  • Pneumothorax1

Recent adverse event reports

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

  • InjuryJan 5, 2021Disconnection; Material Separation; Disconnection; Material Separation

    MATERIAL NO.: TPT1005SP; BATCH NO.: 0001381128. IT WAS REPORTED THAT WHEN REMOVING THE METAL STYLET, THE BALL VALVE AND MEMBRANE MECHANISM PULLED OUT OF THE 3 WAY HOUSING. PER ATTACHED FORM: PER THE PHYSICIAN: "AFTER PUNCTURE, WHEN REMOVING THE METAL STYLET, THE BALL VALVE AND MEMBRANE MECHANISM PULLED OUT OF THE 3WAY HOUSING. THIS ALLOWED AIR TO TRAVEL QUICKLY INTO THE PLEURAL SPACE. I WAS NOT ABLE TO COVER IT WITH MY FINGER DUE TO ITS IRREGULAR SHAPE, AND IT TOOK ME A MOMENT TO TURN THE 3WAY TO CLOSED POSITION." CUSTOMER RESPONSE: PLEASE CONFIRM WHETHER OR NOT THERE WAS ANY PATIENT IMPACT. PATIENT DEVELOPED A MODERATE PNEUMOTHORAX. DO YOU HAVE PHOTOS SHOWING THE REPORTED ISSUE? PICTURES ATTACHED. WHAT PROCEDURE WAS BEING DONE WHEN THE REPORTED ISSUE OCCURRED? THORACENTESIS. PLEASE USE THE ATTACHED PRE-PAID SHIPPING LABEL TO RETURN INSTRUMENT FOR INVESTIGATION. THE DEVICE WAS NOT SAVED.

    Patient problems: Pneumothorax

    MAUDE report 11119794 ↗

Other Thoracentesis tray devices

All Thoracentesis tray devices →

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