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Dover PP14SDRecalls & reported problems

Cardinal Health 200, LLC · 100% SILICONE FOLEY TRAY, LUER LOCK, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECUREMENT · Class 2

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521029675), received between Sep 16, 2020 and Jun 16, 2023 — classified as 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-1046-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Break1
  • Detachment of Device or Device Component1
  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • 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.

  • MalfunctionJun 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    THE CUSTOMER REPORTED THAT THIS PRODUCT FELL OUT OF THE PATIENT TWICE. THERE APPEARED TO BE A SPLIT IN THE BALLOON. PER ADDITIONAL INFORMATION RECEIVED, AN ED (EMERGENCY DEPARTMENT) VISIT WAS REQUIRED AND A DIFFERENT CATHETER WAS PLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17146186 ↗
  • MalfunctionSep 16, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE FOLEY WAS PLACED ON (B)(6) 2020 AT 19:15 AND BROKE ON (B)(6) 2020 AT 19:50 DURING PATIENT REPOSITIONING. THE CATHETER SILICONE MATERIAL RIPPED AND HAD BECOME LACERATED WHEN REPOSITIONING THE PATIENT. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10543345 ↗

Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices

All COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices →

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