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Dover 6308LLRecalls & reported problems

Cardinal Health, Inc. · Urine Drainage Bag,Luer-Lock Sampling, Anti-Reflux Device, Drain Port · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521002708), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Misassembly by Users” (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

  • Misassembly by Users1

Patient problems

  • Abdominal Distention1
  • Tachycardia1

Recent adverse event reports

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

  • InjuryAug 8, 2023Misassembly by Users; Misassembly by Users

    THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH THE SILICONE CAP COVER IN A FOLEY BAG KIT. A 71 Y/O MALE WAS SENT TO THE ED WITH A 3 WAY FOLEY CATHETER IN PLACE. THE PATIENT PRESENTED WITH GROSS HEMATURIA AND A NEED FOR A BLOOD TRANSFUSION FOLLOWING A UROLOGY OFFICE VISIT. ADMISSION ORDERS WERE PLACED INCLUDING AN ORDER FOR BLADDER IRRIGATION. THE PATIENT WAS TRANSFERRED FROM THE ED TO 4 EAST AT 10:00PM WITH THE 3-WAY FOLEY CATHETER IN PLACE. UPON ARRIVAL THE FLOOR RN OBSERVED A DISTENDED ABDOMEN AND THE PATIENT WAS COMPLAINING OF PAIN. CONTINUOUS BLADDER IRRIGATION (CBI) FLUIDS WERE RUNNING BUT NO ACTIVE OUTPUT WAS NOTED. ATTEMPTS WERE MADE TO IRRIGATE THE FOLEY TO REMOVE CLOTS. THE NURSE NOTICED A CAP ON THE CATHETER BAG WAS INSERTED INTO THE OUTPUT PORT BLOCKING OUTPUT. THE CAP WAS REMOVED AND REPORTED TO HER SUPERVISORS. THE MEDICINE PROVIDER ORDERED PAIN MEDICATION AND CT ABDOMEN/PELVIS. AT 12:51, RESULTS OF THE CT SHOWED A POSSIBLE BLADDER PERFORATION. AT 01:27, THE PATIENT DEVELOPED TACHYCARDIA, LOW BLOOD PRESSURE AND WAS ADMITTED TO THE ICU. AT 6:00AM, TO OR EXPLORATORY LAPAROTOMY/CYSTOSCOPY (NOTE STATED PERFORATION OF BLADDER DUE TO OVER DISTENTION). PER ADDITIONAL INFOR

    Patient problems: Abdominal Distention; Tachycardia

    MAUDE report 17483822 ↗

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

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