Silicone Round Double Drain 0070730Recalls & reported problems
C. R. Bard, Inc. · Silicone Round Double Drain, Medium 1/4" (19Fr., 6.3mm) O.D., 49" (124.4cm) Long, 12.25" (31.2cm)Middle Hole Pattern, X-Ray Opaque Stripe, Attached Trocar · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741049552), received between Nov 14, 2018 and Nov 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (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.
Most reported problems
Device problems
- Obstruction of Flow1
- Use of Device Problem1
Patient problems
- No Code Available1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2018Use of Device Problem; Use of Device Problem; Obstruction of Flow
IT WAS REPORTED THAT THE DRAIN TUBE WAS NOT OPENED. THE DAY AFTER PLACEMENT OF THE DRAIN THE PATIENT REPORTED TO THE SURGICAL CLINIC AND IT WAS NOTICED COPIOUS AMOUNTS OF DRAINAGE FROM THE PERI-DRAIN SITE. UPON REMOVAL OF THE DRAIN, IT WAS NOTED THAT APPROXIMATELY 3/4" OF THE DRAIN WAS FULL OF SILICON. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2018 THAT THE DRAIN WAS NOT REPLACED. THE DRAIN WAS NOT SCHEDULED TO BE REMOVED; HOWEVER, IT WAS REMOVED THE FOLLOWING DAY DUE TO THE PATENCY ISSUE. THE DRAIN HAD BEEN ORIGINALLY PLACED FOR POST OPERATIVE WOUND DRAINAGE.
Patient problems: No Code Available; Patient Problem/Medical Problem
MAUDE report 8071955 ↗
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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