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Frederick Miller G05276Recalls & reported problems

Cook Incorporated · Frederick Miller Feeding Tube · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002052765), received between Feb 1, 2017 and Feb 15, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Hole In Material2
  • Leak/Splash2

Patient problems

  • No Code Available2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 15, 2018Leak/Splash

    THE COMPLAINANT REPORTED THAT FORMULA WAS LEAKING FROM THE HUB OF THE TUBE. THE DEVICE WAS PLACED NASALLY INTO THE JEJUNUM AND IT WAS IN PLACE FOR APPROXIMATELY 5 MONTHS BEFORE IT WAS REMOVED. ASIDE FROM REPLACING THE DEVICE, THERE WERE NO ADDITIONAL EFFECTS TO THE PATIENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7272564 ↗
  • MalfunctionJun 23, 2017Leak/Splash; Leak/Splash

    CUSTOMER REPORTED THAT A PATIENT UNDERWENT FLUOROSCOPIC PLACEMENT OF A COOK FREDERICK-MILLER FEEDING TUBE. PLACEMENT WAS CONFIRMED WITH BARIUM INJECTION. THE DEVICE BEGAN TO LEAK WATER WHEN THE TUBE WAS BEING RINSED. THE TUBE WAS REMOVED AND ANOTHER PLACED DURING THE SAME PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6662620 ↗
  • InjuryFeb 1, 2017Hole In Material; Hole In Material

    CUSTOMER REPORTED THAT A PATIENT HAD A FREDERICK-MILLER FEEDING TUBE PLACED ON (B)(6) 2016. HOLES WERE OBSERVED IN THE TUBES AFTER INJECTION OF CONTRAST. THE FEEDING TUBE WAS REMOVED AND REPLACED. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 6292743 ↗
  • InjuryFeb 1, 2017Hole In Material; Hole In Material

    CUSTOMER REPORTED THAT A PATIENT HAD A FREDERICK-MILLER FEEDING TUBE PLACED ON (B)(6) 2017. HOLES WERE OBSERVED IN THE TUBES AFTER INJECTION OF CONTRAST. CONTRAST "FILLED THE BOWEL, AS EXPECTED (FROM THE MANUFACTURED END HOLES), BUT ALSO FILLED THE UPPER ESOPHAGUS." THE FEEDING TUBE WAS REMOVED AND REPLACED. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 6292738 ↗

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Sources and updates

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