CARDINAL HEALTH SU130-1323 (UDI 10885380064067)Recalls & reported problems
Cardinal Health 200, LLC · DRAIN JACKSON PRATT ROUND 15FR · 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 10885380064067), received between May 10, 2017 and Mar 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Detachment of Device or Device Component1
Patient problems
- Abscess1
- Adhesion(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2019Break; Detachment of Device or Device Component
A JP DRAIN BROKE OFF IN PATIENT DURING REMOVAL. PATIENT SENT BACK TO SURGERY AND DRAIN FRAGMENT SUCCESSFULLY REMOVED. PATIENT LATER DISCHARGED HOME AND RECOVERING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8437436 ↗MalfunctionMay 10, 2017Break
PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR AN EVACUATION OF ABDOMINAL PELVIC ABSCESS, LYSIS OF ADHESION'S AND WOUND DEBRIDEMENT. TWO ABDOMINAL DRAINS WERE PLACED. ON (B)(6) 2017, THE SURGEON WAS REMOVING THE DRAINS AS PLANNED WHEN THE LEFT SIDED DRAIN BROKE, LEAVING THE DISTAL END IN THE ABDOMEN. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2017 TO REMOVE THE PIECE OF DRAIN. SHE WAS DISCHARGED HOME ON (B)(6) 2017.
Patient problems: Abscess; Adhesion(s)
MAUDE report 6558630 ↗
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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