Silicone Round Double Drain 0070720Recalls & reported problems
C. R. Bard, Inc. · Silicone Round Double Drain, Medium 3/16" (15Fr., 4.7mm) O.D., 49" (124.4cm) Long, 12.25" (31.2cm)Middle Hole Pattern, X-Ray Opaque Stripe, Attached Trocar · Class 1
Data updated Oct 18, 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 00801741049545), received between Sep 2, 2020 and Sep 2, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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
Device problems
- Dull, Blunt2
- Difficult to Advance1
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2020Dull, Blunt
IT WAS REPORTED THAT THE TROCAR WAS DULL AND DIFFICULT TO PENETRATE INTO THE SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10485313 ↗MalfunctionSep 2, 2020Dull, Blunt; Difficult to Advance
IT WAS REPORTED THAT THE TROCAR WAS DULL AND DIFFICULT TO PENETRATE INTO THE SKIN.
Patient problems: Insufficient Information; No Consequences Or Impact To Patient
MAUDE report 10485307 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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