Davol Bile Bag, Regular 0015850Recalls & reported problems
C. R. Bard, Inc. · Bile Bag · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741011610), received between Jan 10, 2019 and Sep 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
- Material Fragmentation1
- Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Material Fragmentation
It was reported that while the Registered nurse was disconnecting the bile (or it may be referred to as a Billi bag) from the patient, the connector piece inserted into the patient broke in half during removal. The Registered nurse retrieved all broken pieces, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740854 ↗MalfunctionJan 10, 2019Misassembled; Device Misassembled During Manufacturing /Shipping; Misassembled
IT WAS REPORTED THAT THE PRINT ON THE BILE BAG APPEARED TO HAVE BEEN ASSEMBLED UPSIDE DOWN.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8232835 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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