Silicone Round Drain 0070330Recalls & reported problems
C. R. Bard, Inc. · Silicone Round Drain, Large 1/4" (19Fr., 6.3mm) O.D., 49" (124.4cm) Long, 10" (25.4cm) Hole Pattern, X-Ray Opaque Stripe with Attached Trocar · Class 1
All models of Silicone Round Drain (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741049484), received between Dec 3, 2018 and Mar 24, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material2
- Contamination /Decontamination Problem1
- Corroded1
- Material Puncture/Hole1
- Misassembled1
- Packaging Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2022Corroded; Corroded
IT WAS REPORTED THAT THE NURSE SPOTTED RUST ON THE WOUND DRAIN. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON (B)(4) 2022, CUSTOMER STATED THAT BEFORE OPENING PACKAGE FOR SURGERY CASE, NURSE NOTICED RUST ON TROCAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13892013 ↗MalfunctionDec 12, 2019Misassembled; Misassembled; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS NO HOLE IN THE MIDDLE TO WIRE THE DRAIN.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9457323 ↗MalfunctionDec 10, 2019Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THE USER FOUND A FOREIGN MATERIAL INSIDE THE PACKAGE PRIOR TO OPENING IT.
Patient problems: No Patient Involvement
MAUDE report 9443900 ↗MalfunctionDec 3, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A HAIR WITHIN THE WOUND DRAIN PACKAGE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8125348 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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