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Dover 6146LLRecalls & reported problems

Cardinal Health, Inc. · 100% Silicone Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-Connected to 2000 mL Drainage Bag with Luer-Lock Sampling · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521015500), received between Jun 5, 2019 and May 18, 2021 — classified as 1 injury, 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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. Dec 4, 2023Open, Classified

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

    Z-1050-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1
  • Disconnection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT A MOTHER/BABY EDUCATOR BROUGHT A FOLEY SET TO HER. THE RN OPENED THE PACKAGE TO SET UP FOR INSERTION AND FOUND THE FOLEY BROKEN APART FROM THE DRAINAGE BAG. IT CAME OUT OF THE PACKAGE LIKE THAT. THE DAMAGE WAS IDENTIFIED IMMEDIATELY. THE ITEMS NEVER MADE IT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11845082 ↗
  • InjurySep 23, 2019Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT UPON REMOVAL OF CATHETER, ABOUT 3/4 INCH OF THE END OF THE CATHETER WAS MISSING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE CATHETER WAS IN PLACE LESS THAN 24 HOURS AND REMOVED AFTER DELIVERY. IT WAS USED ON A FEMALE PATIENT. A FLEX CYSTOSCOPY PROCEDURE WAS PERFORMED TO LOOK FOR THE MISSING END OF THE CATHETER. NO MISSING END OF THE CATHETER WAS FOUND INSIDE THE PATIENT. THE PATIENT IS CURRENTLY DOING WELL WITH NO ISSUES.

    Patient problems: No Code Available

    MAUDE report 9105791 ↗
  • MalfunctionJun 5, 2019Break; Break

    THE CUSTOMER REPORTED THAT THEY HAD DIFFICULTY REMOVING THE CATHETER FROM THE PORT. THE CATHETER RIPPED AND BROKE INTO TWO PIECES. ONE PART WAS STILL CONNECTED TO THE SAMPLE PORT.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8671422 ↗

Other CATHETER, RETENTION TYPE, BALLOON devices

All CATHETER, RETENTION TYPE, BALLOON devices →

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