Bard Button Device Continuous Feeding Tube with 90° Adaptor 000258Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741080845), received between Oct 17, 2017 and Jul 16, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 16, 2019Leak/Splash; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000258 FEEDING TUBE ALLEGEDLY EXPERIENCED A LEAK. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8796402 ↗
• MalfunctionNov 20, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS AN ALLEGED LEAK IN THE CONNECTION BETWEEN THE GASTROSTOMY TUBE AND BUTTON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092393 ↗
• MalfunctionNov 8, 2017Detachment Of Device Component; Leak/Splash

  IT WAS REPORTED TO MS&S THAT THE PATIENT IS EXPERIENCING THE FEEDING TUBE ADAPTER "POPPING OUT" AND LEAKING. MS&S ADVISED THE BARD BUTTON CONTINUOUS FEEDING TUBE ADAPTER FOR THE 24FR. BUTTON IS TYPICALLY USED FOR PUMP FEEDING. THE BOLUS TUBE IS FOR SYRINGE FEEDING WHICH MIGHT HELP IF THE PRESSURE FROM THE PUMP IS TOO MUCH. IF THE EXTENSION TUBE POPS OUT, IT IS POSSIBLE THE DEVICE HAS BEEN STRETCHED OUT OVER TIME AND MAY NEED TO BE REPLACED. IT IS ALSO POSSIBLE AIR / GAS ARE PUSHING IT OUT SO USING A DECOMPRESSION TUBE, MAY HELP. MS&S ALSO SUGGESTED DECOMPRESSING THE BELLY SINCE THE ADAPTER "POPS OUT" WHEN THE PATIENT COUGHS.

  Patient problems: No Information

  MAUDE report 7010406 ↗
• MalfunctionOct 17, 2017Hole In Material; Unsealed Device Packaging; Material Integrity Problem

  IT WAS REPORTED BY THE FACILITY THAT WHEN THE PACKAGE WAS OPENED THEY ALLEGED A POSSIBLE ISSUE WITH THE PRODUCT MOLDING; THEY NOTICED WHAT APPEARED TO LOOK LIKE A PIN HOLE BY THE "BELL SHAPE" ON THE TUBE. DEVICE WAS NOT USED ON PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956478 ↗