CARDINAL HEALTH SU130-1310 (UDI 10192253022360)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10192253022360), received between Jul 20, 2020 and Mar 3, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Separation

  CUSTOMER REPORTED A SILICONE ROUND DRAIN, JACKSON-PRATT, 7FR, BROKE INTO TWO PIECES POST OPERATIVELY. EXISTING DRAIN WAS STILL USED AND REMAINING TUBING WAS RECONNECTED TO THE BULB. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501572 ↗
• InjuryApr 24, 2025Material Separation; Material Separation

  CUSTOMER REPORTED OF DRAIN REMOVAL ATTEMPTED AT BEDSIDE BY RN. RN NOTES THAT APPROXIMATELY ONE INCH OF THE DISTAL TIP OF THE DRAIN WAS BROKE OFF WHEN REMOVED AND NOTIFIED MD. PATIENT TAKEN BACK TO SURGERY ON (B)(6) 2025 TO REMOVE RETAINED DRAIN FROM THE INTRAMUSCULAR SPACE IN THE RIGHT LOWER QUADRANT. SURGEON WAS ABLE TO VISUALIZE DRAIN BEFORE REMOVAL AND NOTES "NO ENTANGLEMENT WITH SUTURES OR THE SURROUNDING SOFT TISSUES". ABDOMEN INSPECTED FOR ADDITIONAL PIECES, BUT NONE FOUND. THE PATIENT WAS RECOVERED AND ABLE TO BE DISCHARGED THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21902067 ↗
• InjuryFeb 12, 2025Material Fragmentation; Material Fragmentation

  PATIENT UNDERWENT A BIFRONTAL CRANIOTOMY. WHILE THE JP DRAIN THAT WAS PLACED DURING SURGERY WAS BEING REMOVED AT THE BEDSIDE, THE DRAIN TUBING SNAPPED. CT OF HEAD SHOWED A RADIOPAQUE TUBULAR STRUCTURE IN THE FRONTAL SCALP WITH IRREGULARITY OF A PORTION OF THE DRAIN ON THE LEFT, WHERE THERE WAS PREVIOUSLY EXTENSION OF THE CATHETER TUBING THROUGH THE TEMPORAL SCALP AND OUTSIDE OF THE SKIN. PATIENT WAS TAKEN TO THE OR FOR REMOVAL OF THIS RETAINED CATHETER FRAGMENT. FRAGMENT SUCCESSFULLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21370329 ↗
• InjuryMay 3, 2023Break; Break

  TWO JP DRAINS WERE REMOVED. ONE WAS REMOVED INTACT, BUT THE SECOND JP DRAIN BROKE, AND A PIECE WAS RETAINED. THERE WERE NO ADDITIONAL DETAILS OR CONTACT INFORMATION RECEIVED ON MEDWATCH MW5116310.

  Patient problems: Insufficient Information

  MAUDE report 16865223 ↗
• InjuryMay 3, 2023Break; Break

  TWO JP DRAINS WERE REMOVED. ONE WAS REMOVED INTACT, BUT THE SECOND JP DRAIN BROKE, AND A PIECE WAS RETAINED. THERE WERE NO ADDITIONAL DETAILS OR CONTACT INFORMATION RECEIVED ON MEDWATCH MW5116309.

  Patient problems: Insufficient Information

  MAUDE report 16865219 ↗
• InjuryMay 3, 2023Break; Break

  TWO JP DRAINS WERE REMOVED. ONE WAS REMOVED INTACT, BUT THE SECOND JP DRAIN BROKE, AND A PIECE WAS RETAINED. THERE WERE NO ADDITIONAL DETAILS OR CONTACT INFORMATION RECEIVED ON MEDWATCH MW5116308.

  Patient problems: Insufficient Information

  MAUDE report 16865207 ↗
• InjuryMay 3, 2023Break; Break

  TWO JP DRAINS WERE REMOVED. ONE WAS REMOVED INTACT, BUT THE SECOND JP DRAIN BROKE, AND A PIECE WAS RETAINED. THERE WERE NO ADDITIONAL DETAILS OR CONTACT INFORMATION RECEIVED ON MEDWATCH MW5116307.

  Patient problems: Insufficient Information

  MAUDE report 16865200 ↗
• InjuryAug 4, 2020Break; Entrapment of Device

  THE CUSTOMER REPORTED THE DRAIN BROKE OFF INSIDE THE PATIENT AND REQUIRED SURGICAL REMOVAL. THE DRAIN WAS DISCARDED BY THE CUSTOMER. NO OTHER INFORMATION WAS PROVIDED AS THE HOSPITAL IS STRICT IN PROVIDING INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10363036 ↗
• InjuryJul 20, 2020Break

  CUSTOMER REPORTED THE JP DRAIN WAS REMOVED FROM PATIENT. HEALTHCARE PROVIDER FELT PORTION OF DRAIN RETAINED. X-RAY DID NOT REVEAL THE RETAINED PIECE OF JP DRAIN. A CT SCAN WAS DONE AND IDENTIFIED PORTION OF JP DRAIN. IT WAS NOTED BY THE RADIOLOGIST THAT THE ¿JP DRAIN WAS NOT SUFFICIENTLY ABLE TO BE VISUALIZED AND THAT THE MANUFACTURER SHOULD ENHANCE THE PRODUCT TO BE MORE X-RAY DETECTABLE." ADDITIONALLY, CUSTOMER STATED THE DRAIN BROKE OFF IN ABDOMEN DURING REMOVAL AFTER BEING PLACED IN PATIENT FOR NINE DAYS. AS A RESULT, THE (B)(6) YEAR-OLD MALE REQUIRED SURGICAL PROCEDURE FOR REMOVAL OF BROKEN PORTION OF JP DRAIN. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED WITHOUT ANY ADDITIONAL TREATMENT OR MEDICATIONS. PATIENT DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 10299524 ↗