CARDINAL HEALTH SU130-1321 (UDI 10192253022407)Recalls & reported problems
Cardinal Health 200, LLC · DRAIN JACKSON PRATT 10FR 1/8END · Class 1
Data updated Oct 18, 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 10192253022407), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2024Break; Break
CUSTOMER REPORT THAT ON (B)(6) 2024, A 72-YEAR-OLD MALE PATIENT GOT RIGHT KNEE UKA PAIN AND WAS ADMITTED TO OUR HOSPITAL FOR OPERATION. THE PATIENT UNDERWENT RIGHT REVISION TOTAL KNEE REPLACEMENT ON THE SAME DAY AND A WOUND DRAIN WAS INSERTED. ON (B)(6) 2024, THE DRAIN WAS REMOVED AND THE PATIENT DISCHARGED TO HOME. ON 8/1/2024, WE WERE INFORMED BY THE DOCTOR THAT DURING FOLLOW-UP CONSULTATION, KNEE X-RAY REVEALED A FOREIGN BODY WAS INSIDE THE PATIENT'S RIGHT KNEE AND SCHEDULED ON (B)(6) 2024 TO UNDERGO OPERATION FOR REMOVAL OF FOREIGN BODY. A 6.5CM FOREIGN BODY (PART OF THE DRAIN) WAS RETRIEVED AND PATIENT DISCHARGED ON THE SAME DAY. NO ADVERSE SYMPTOMS DETECTED. THE HOSPITAL REPORTED THE CASE TO THE SUPPLIER ON 8/15/2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236142 ↗
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