CARDINAL HEALTH SU130-0321 (UDI 10192253022230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10192253022230), received between Jun 10, 2022 and Dec 11, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THE JP DRAIN TIP BROKE AND REMAINED IN PATIENT AT TIME OF REMOVAL. PATIENT HAD TO BE TAKEN BACK TO SURGERY TO REMOVE THE JP DRAIN TIP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23784932 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN BROKE WHILE NURSE WAS EMPTYING THE DRAIN. DRAIN WAS PULLED AND NOT REPLACED. ONE NURSE EVEN NOTES THE TUBING LOOKED ¿OFF¿. WHEN QUESTIONED SHE SAID IT LOOKED WORN, ALMOST LIKE IT WAS OLD. ALL DRAINS WERE WITHIN THE ALLOTTED TIME FRAME FOR USAGE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599232 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT WHILE THE NURSE WAS EMPTYING THE DRAIN, SHE NOTICED THE TUBING LOOKED ¿OFF¿. SHE GENTLY MILKED THE TUBING, AND IT BROKE COMPLETELY IN ONE PLACE AND PARTIALLY IN ANOTHER. DRAIN WAS REMOVED, NOT REPLACED. ONE NURSE EVEN NOTES THE TUBING LOOKED ¿OFF¿. WHEN QUESTIONED SHE SAID IT LOOKED WORN, ALMOST LIKE IT WAS OLD. ALL DRAINS WERE WITHIN THE ALLOTTED TIME FRAME FOR USAGE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598894 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN TUBING BROKE INTO TWO PIECES WHILE BEING EMPTIED. THIS LED TO IT NEEDING TO BE REMOVED. DRAIN WAS NOT REPLACED. ONE NURSE EVEN NOTES THE TUBING LOOKED ¿OFF¿. WHEN QUESTIONED SHE SAID IT LOOKED WORN, ALMOST LIKE IT WAS OLD. ALL DRAINS WERE WITHIN THE ALLOTTED TIME FRAME FOR USAGE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598724 ↗
• MalfunctionOct 18, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT AFTER A L4/L5 POSTERIOR LAMINECTOMY FOR RESECTION OF SYNOVIAL CYSTS, DECOMPRESSION AND INSTRUMENTED FUSION WITH PEDICLE SCREWS (BACK), USE OF OPERATING MICROSCOPE (BACK), ULTRASOUND GUIDANCE, INTRAOPERATIVE (BACK), POSTERIOR ARTHRODESIS, SINGLE LEVEL, LUMBAR (SPINE LUMBAR), POSTERIOR INSTRUMENTATION LEVEL 1 (BACK), ALLOGRAFT MORSELIZED (BACK), AUTOGRAFT SPINE SURGERY LOCAL FROM SAME INCISION (BACK), PATIENT DEVELOPED A WOUND INFECTION REQUIRING A WASH OUT AND REMOVAL OF INSTRUMENTATION. FOLLOWING THE SECOND SURGERY, THE DRAIN WAS BEING ¿MILKED¿ BY THE RN WHEN IT SNAPPED OFF. PLACED FRACTURED. VACUUM SUCTION APPLIED TO THE SKIN, JP REATTACHED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23332786 ↗
• InjuryOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT ON THE EVENING OF DAY OF SURGERY FOR A REVISION HEMILAMINECTOMY L2-3 RIGHT (BACK), THE PATIENT WAS BLEEDING HEAVILY FROM THE SURGICAL SITE INTO AND AROUND THE JP DRAIN. THEN THE PATIENT SUDDENLY HAD MINIMAL DRAINAGE OUTPUT. DR. ORDERED STRIPPING DRAIN TUBING. WHEN THIS WAS DONE THE TUBING SNAPPED EASILY WITH MINIMAL PRESSURE TO TUBING. THIS THEN REQUIRED A RETURN TO THE OPERATING ROOM. UNDER ANESTHESIA, A HEMATOMA WAS EVACUATED, THE WOUND WAS WASHED OUT, AND TWO NEW SURGICAL DRAINS WERE PLACED. THE PATIENT FULLY RECOVERED.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330889 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT DURING THE PROCEDURE: A POSTERIOR CERVICAL DECOMPRESSION & FUSION C2-6, LAMINECTOMY C2-6, ILIAC CREST BONE MARROW ASPIRATION (SPINE CERVICAL), THE SCRUB TECH SHOWED THE NURSING MANAGER HOW EASILY THE DRAIN BROKE AND FRACTURED INTO PIECES. THE DEVICE WAS NOT USED FOR THIS PATIENT. IT WAS REPLACED WITH A DIFFERENT DRAIN AND RESERVOIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330607 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  CUSTOMER REPORTED A JP DRAIN TUBING FRACTURE. CUSTOMER IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22207158 ↗
• InjuryJun 12, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT A PATIENT HAD A RETURN TO SURGERY FOR A FRACTURED JP DRAIN. PER MD, "DRAIN TUBING BROKEN WITH RETROGRADE FLOW OF BLOOD AND ANTEROGRADE FLOW OF BLOOD". THIS RESULTED IN RETURN TO THE OR FOR EVACUATION OF HEMATOMA AND REPLACEMENT OF THE DRAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22198741 ↗
• InjuryMar 18, 2023Break; Break

  MW1100340000-2023-8002 STATES: CUSTOMER REPORTED A 10 FRENCH ROUND JACKSON PRATT DRAIN HAS BEEN FOUND TO BE BREAKING AND LEAVING REMNANTS INSIDE THE PATIENT. NO DEMOGRAPHICS OR ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570218 ↗
• InjuryJun 10, 2022Fracture; Fracture

  A 10FR CHANNEL DRAIN WAS PLACED IN PATIENT DURING SURGERY. REGISTERED NURSE MET RESISTANCE WHEN ATTEMPTING TO REMOVE. NURSE NOTIFIED THE PHYSICIAN WHO GUIDED HER THROUGH THE REMOVAL OF THE JP DRAIN. THE TIP OF THE DEVICE WAS EXAMINED AND APPEARED INTACT. DURING A FOLLOW UP VISIT, A SURGEON NOTED RETAINED FOREIGN OBJECT THAT WAS A PIECE OF BROKEN JP DRAIN. PATIENT RETURNED TO SURGERY AND RETAINED DRAIN TUBING WAS SUCCESSFULLY REMOVED. ACCORDING TO THE MEDICAL RECORD, A SCALPEL WAS USED TO MAKE A SMALL INCISION TO REMOVE THE DRAIN FROM THE PATIENT. THE BROKEN SECTION WAS REMOVED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT REQUIRED STITCHES. PATIENT WAS DISCHARGED HOME THE SAME DAY. WE HAVE RECEIVED NO ADDITIONAL INFORMATION ON HOW PATIENT IS DOING NOW.

  Patient problems: Foreign Body In Patient

  MAUDE report 14658546 ↗