CARDINAL HEALTH SU130-1311 (UDI 10192253022377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253022377), received between Jul 25, 2024 and Mar 10, 2026 — classified as 3 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Material Separation

  THE CUSTOMER REPORTED THAT DURING REMOVAL, THE FENESTRATED PORTION OF THE DRAIN PLACED IN THE LOWER BACK, LUMBAR REGION, BROKE OFF INSIDE OF THE PATIENT. PATIENT WAS TAKEN TO THE OPERATING ROOM TO REMOVE FENESTRATED DRAIN PORTION. BROKEN PIECE WAS RETRIEVED. PATIENT IS NOW OTHERWISE DOING WELL. THE SURGEON STATED THE PRODUCT MALFUNCTIONED AND IT WAS NOT USER ERROR.

  Patient problems: Foreign Body In Patient

  MAUDE report 24562962 ↗
• InjuryNov 14, 2024Break; Break

  ON (B)(6) 2024, THE BEDSIDE NURSE AND HER ORIENTEE WERE DISCONTINUING JP DRAIN FROM PATIENT'S LEFT LEG VEIN GRAFT SITE PER PROTOCOL. NURSE FELT SLIGHT RESISTANCE CONSISTENT WITH TYPICAL JP DRAIN REMOVAL. BULB REMOVED TO ENSURE NO VACUUM PRESENT AND CONTINUED TO REMOVE JP DRAIN. FLEXIBLE CONNECTING TUBING SUDDENLY SHEARED OFF FROM CONNECTION SITE TO DRAINAGE TUBING. DRAINAGE TUBING STAYED INSIDE PATIENT'S VEIN GRAFT SITE, UNABLE TO VISUALIZE. (B)(6) NOTIFIED ME AND I ALSO COULDN'T VISUALIZE THE END OF THE DRAINAGE TUBING STILL INSIDE THE PATIENT'S LEG. SURGEON GAVE A SMALL AMOUNT OF LOCAL ANESTHETIC AT THE SITE WHERE THE DRAIN WAS EXITING THE PATIENT¿S LEG. UITRASOUND WAS USED TO VISUALIZE THE RETAINED PORTION OF THE DRAIN AND A TONSIL CLAMP WAS INSERTED INTO THE EXISTING INCISION AND RETAINED PORTION WAS PULLED OUT FROM THERE. THE CUSTOMER IS UNSURE IF THE DEVICE HAD A LOT NUMBER OF 1240323 OR 1240326.

  Patient problems: Foreign Body In Patient

  MAUDE report 20690582 ↗
• InjuryJul 25, 2024Break; Break

  MED WATCH REPORT NUMBER 1002890000-2024-8006: THE PATIENT UNDERWENT A LIVER TRANSPLANT. DURING THE FOLLOW UP OFFICE VISIT OVER 3 WEEKS LATER, THE PHYSICIAN ATTEMPTED TO REMOVE THE JACKSON-PRATT (JP) DRAIN, BUT IT BROKE OFF. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE REMAINING PART. PATIENT WAS GIVEN GENERAL ANESTHESIA. THE PIECE WAS REMOVED BY OPENING OF THE SKIN AND SUBCUTANEOUS AND EXTENDING ALL OBLIQUE FASCIA, RETRIEVAL OF THE REMNANT OF THE JP DRAIN, CLOSURE OF THE EXTERNAL FASCIA AND SKIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19831004 ↗