Biliary Drainage Tube PBD-421-1007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170046940), received between Sep 3, 2020 and Mar 16, 2026 — classified as 1 injury, 2 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.

• MalfunctionMar 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, WHEN THE BILIARY DRAINAGE TUBE WAS REMOVED, IT WAS DETERMINED THAT 3 OF THE 4 FLAPS ON THE STENT WERE MISSING AND HAD DETACHED. THERE WAS NO REPORT OF PATIENT HARM. THIS IS REPORT 4 OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606535 ↗
• InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THE DRAIN WAS REMOVED USING A SNARE, AND AT THE TIME OF RETRIEVAL, ONLY ONE FLAP REMAINED ATTACHED TO THE DRAINAGE DEVICE. IT WAS ASSUMED THAT THE ALL FLAPS HAD ALREADY PASSED THROUGH THE INTESTINES, REACHED THE SMALL BOWEL, AND WERE NATURALLY EXCRETED, AND NO DIAGNOSTICS WERE PERFORMED. THE MEDICAL TEAM THEN RETRIEVED A SECOND DRAIN FROM WHICH THREE FLAPS HAD ALSO DETACHED; THIS DEVICE REMAINED SECURED BY ONLY ONE FRAGILE FLAP AND WAS AT RISK OF INTERNAL DISLOCATION. DURING RETRIEVAL OF THE SECOND DRAIN, THE FINAL REMAINING FLAP ALSO TORE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 23750830 ↗
• 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 THIRD ONE OF FIVE REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486777 ↗