Bard PEG Safety System 006036Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741081194), received between Nov 7, 2017 and Oct 11, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT UPON OPENING THE FEEDING DEVICE KIT, THE TIP OF THE GUIDEWIRE WAS ALLEGEDLY FRAYED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9182540 ↗
• MalfunctionJul 24, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 006036 FEEDING DEVICE ALLEGEDLY HAD FOREIGN MATERIAL ON THE SHAFT OF THE DEVICE. THE FOREIGN MATERIAL WAS REMOVED AND PLACEMENT OF THE DEVICE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821970 ↗
• MalfunctionApr 19, 2019Material Frayed; Defective Component; Material Frayed; Defective Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 006036 FEEDING DEVICE ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS REPORT WAS RECEIVED FROM ONE SOURCE. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE AGE, SEX, AND WEIGHT OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532941 ↗
• MalfunctionAug 1, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE FLEXIBLE PART OF THE GUIDE WIRE WAS ALLEGEDLY MUCH LONGER THAN USUAL. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 7739563 ↗
• MalfunctionApr 17, 2018Break

  IT WAS REPORTED THAT WHEN KIT WAS OPENED, THE GUIDEWIRE WAS NOTED TO BE DAMAGED. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7438554 ↗
• MalfunctionFeb 22, 2018Break; Sticking

  IT WAS REPORTED BY THE FACILITY THAT THE GUIDEWIRE WAS DAMAGED. SALES REP STATED THE GUIDEWIRE WAS STUCK IN THE "HOLDER". NO OTHER INFORMATION PROVIDED. NO PATIENT INJURY REPORTED. 02/01/2018-RETURNED SAMPLE FOUND CORE WIRE OF THE GUIDEWIRE WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289985 ↗
• MalfunctionFeb 6, 2018Break

  IT WAS REPORTED THAT THE GUIDEWIRE WAS DAMAGED DURING USE. A NEW DEVICE WAS REQUIRED TO COMPLETE THE PROCEDURE, BUT THERE IS NO INDICATION THAT THE EVENT RESULTED IN PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7246309 ↗
• MalfunctionNov 7, 2017Break

  IT WAS REPORTED THAT THE GUIDEWIRE WAS DAMAGED PRIOR TO USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7007467 ↗