Bard® Premature Infant Feeding Tube 0036400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741034404), received between Mar 19, 2018 and Apr 13, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2020Restricted Flow rate; Inaccurate Flow Rate; No Flow; Restricted Flow rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT UPON PLACING THE FEEDING TUBE IN THE PATIENT CONTRAST DID NOT FLOW THROUGH THE TUBE. AN ATTEMPT TO FLUSH THE TUBE WITH SALINE WAS UNSUCCESSFUL. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9954585 ↗
• MalfunctionFeb 20, 2020Incorrect Measurement; Device Markings/Labelling Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE FEEDING TUBE WAS LABELED WRONG, AND THE TUBE WAS TOO THICK. THE CUSTOMER NOTED THAT HALF THE BOX WAS CORRECT AND HALF WAS NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732711 ↗
• MalfunctionFeb 20, 2020Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE FEEDING TUBE WAS LABELED WRONG, AND THE TUBE WAS TOO THICK. THE CUSTOMER NOTED THAT HALF THE BOX WAS CORRECT AND HALF WAS NOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732704 ↗
• MalfunctionMar 5, 2019Component Missing

  IT WAS REPORTED THAT THE PACKAGING WAS SEALED BUT NO PRODUCT WAS INSIDE.

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

  MAUDE report 8391248 ↗
• MalfunctionMar 19, 2018Misassembled; Mechanical Problem; Misassembled

  IT WAS REPORTED THAT A PATIENT HAD BEEN STRUGGLING WITH BREASTFEEDING HER BABY, ATTEMPTING MULTIPLE TIMES DURING A NURSE'S SHIFT. THE PATIENT HAD BEEN SET UP WITH A NIPPLE SHIELD, FEEDING TUBE AND SYRINGE TO ASSIST HER IN FEEDING HER NEWBORN. AFTER MULTIPLE ATTEMPTS TO FEED THE NEWBORN, IT WAS NOTICED THAT THE NEWBORN WAS STILL UNABLE TO INTAKE THE SUPPLEMENTAL FORMULA FROM THE FEEDING TUBE AND SYRINGE. UPON FURTHER INSPECTION OF THE FEEDING TUBE, THE NURSE NOTICED THAT THE TUBE HAD ONLY ONE HOLE AT THE END OF IT INSTEAD OF TWO. THE INFANT WAS NOT ABLE TO SUCK THE SUPPLEMENTAL FORMULA FROM THE DEVICE. PER ADDITIONAL INFORMATION: THE MOTHER WAS TRYING TO BREASTFEED AND USE THE DEVICE AT THE SAME TIME.

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

  MAUDE report 7350173 ↗