CARDINAL HEALTH SU130-0321 (UDI 10885380063985)Recalls & reported problems
Cardinal Health 200, LLC · DRAIN JACKSON PRATT 10FR 7MM · Class 1
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 10885380063985), received between Nov 4, 2016 and Jan 18, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Detachment Of Device Component2
- Entrapment of Device1
Patient problems
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2018Break
THE ITEM BROKE AS IT WAS BEING REMOVED DAY 4 POST-OP THORACIC SPINE SURGERY. PER THE STAFF MEMBER ATTEMPTING TO REMOVE THE DRAIN, ONLY GENTLE PRESSURE WAS APPLIED AS IT WAS NOT SUTURED IN AND THE DRAIN TUBING SNAPPED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7204219 ↗MalfunctionMay 9, 2017Break; Detachment Of Device Component
FOUND PATIENT'S DRAIN WITH TUBING BROKEN ABOUT 2 INCH AWAY FROM SKIN TAG. THE EDGE OF THE BROKEN PART OF THE TUBING WAS A COMPLETE SHARP END. X-RAY PELVIS TAKE INDICATING, REMAINED PART OF THE TUBE WAS RETAINED IN RIGHT HIP. SUBSEQUENTLY THE TUBING WAS REMOVED BY DOCTOR.
Patient problems: Foreign Body In Patient
MAUDE report 6554097 ↗MalfunctionNov 4, 2016Break; Detachment Of Device Component; Entrapment of Device
ON (B)(6) 2016, PATIENT UNDERWENT TOTAL RIGHT KNEE REPLACEMENT SURGERY. JACKSON-PRATT DRAIN WAS INSERTED TO THE WOUND WITHOUT ANCHORING DURING SURGERY. ON (B)(6) 2016, DURING FOLLOW UP AND IN ROUTINE X-RAY, AN OPAQUE OBLIQUE LINE AT THE INFRAPATELLAR REGION WAS FOUND. OPERATION WAS ARRANGED FOR REMOVAL OF FOREIGN BODY FROM RIGHT KNEE THE SAME DAY. A BROKEN DRAIN WAS FOUND AT RETROPATELLAR REGION AND REMOVED UNEVENTFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 6080132 ↗
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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