Biliary Drainage Tube PBD-421-1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170046926), received between Mar 18, 2019 and Sep 9, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  WE RECEIVED THE FOLLOWING REPORT. THE USER ENCOUNTERED MORE FREQUENT PROBLEMS WITH DOUBLE-LAYER-DRAINS FOR THE BILE DUCT. SINCE THE DISTAL FLAPS DETACHED SEVERAL TIMES, THE DRAIN WAS DISLOCATED AND MORE DIFFICULT TO RETRIEVE EVEN 3-4 MONTHS AFTER INSERTION DUE TO MATERIAL WEAKNESS. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10506274 ↗
• MalfunctionSep 3, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  WE RECEIVED THE FOLLOWING REPORT. *THE USER ENCOUNTERED MORE FREQUENT PROBLEMS WITH DOUBLE-LAYER-DRAINS FOR THE BILE DUCT. SINCE THE DISTAL FLAPS DETACHED SEVERAL TIMES, THE DRAIN WAS DISLOCATED AND MORE DIFFICULT TO RETRIEVE EVEN 3-4 MONTHS AFTER INSERTION DUE TO MATERIAL WEAKNESS. THERE WAS NO PATIENT INJURY REPORTED. NO DEVICES WILL BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE FIRST ONE OF FIVE REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486624 ↗
• MalfunctionMar 18, 2019Break; Break

  ON (B)(6) 2018, THE SUBJECT DEVICE WAS PLACED IN THE BILE DUCT OF A PATIENT WITH CHOLANGITIS. ON (B)(6) 2019, THE BILE DUCT WAS CHECKED FOR STENT REPLACEMENT. IT WAS FOUND THAT THE FLAPS OF THE SUBJECT DEVICE WERE MISSING AND THE SUBJECT DEVICE WAS MIGRATED. THE SUBJECT DEVICE WAS RETRIEVED AND DISCARDED BY THE USER. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING THE MIGRATION OF THE DEVICE AND THE MISSING OF THE FLAPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8427754 ↗