PVC Drain with Trocar 0080700Recalls & reported problems
C. R. Bard, Inc. · PVC Drain with Trocar, Small 3/32" (7 Fr., 2.3mm) O.D., 12.5" (31.7cm) Hole Pattern, X-Ray Opaque Stripe, with Attached Trocar · Class 1 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741050114), received between Jul 25, 2024 and Jul 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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.
Reports received per month
Most reported problems
Device problems
- Disconnection2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE HOSPITAL USER FOUND A HAIR THAT WAS SEALED IN THE SEAL AND PACKAGE FOR THE WOUND DRAIN. USER CURRENTLY ONLY HAD THE ONE PACKAGE THAT WAS AFFECTED. IF NEEDED, THEY HAVE THE PACKAGE AVAILABLE FOR QA TEAM. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14OCT2025, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22530635 ↗MalfunctionAug 20, 2024Disconnection; Disconnection
IT WAS REPORTED THAT WOUND DRAIN DETACHED FROM TROCAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20005377 ↗MalfunctionJul 25, 2024Disconnection; Disconnection
IT WAS REPORTED THAT DOCTOR STATED DURING RECENT SURGERIES, WHEN THEY TRY TO INSERT THE WOUND DRAIN, THE TUBING DID NOT REMAIN ATTACHED TO THE TROCAR, AND IT BECOMES EXTREMELY DIFFICULT TO FULLY INSERT DRAIN AND IT HAPPENED TWICE TODAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19824661 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page