CARDINAL HEALTH SU130-1308Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885380064005), received between Jul 25, 2018 and Dec 17, 2018 — classified as 2 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2018Fracture; Difficult to Remove

  DURING SURGERY FOR REMOVAL OF INSTRUMENTATION, FACET FUSION, TRANSFORAMINAL LUMBAR INTER BODY FUSION L3-S1, THE SURGEON PLACED TWO FLAT 7MM JACKSON PRATT DRAINS. ONE WAS PLACED ON THE LEFT AND ONE ON THE RIGHT THROUGH SEPARATE STAB INCISIONS. MUSCLE AND FASCIA WERE APPROXIMATED USING INTERRUPTED VICRYL SUTURES. SKIN STAPLES AND SKIN GLUE WERE USED TO APPROXIMATE THE SKIN. THE NEXT DAY, THE SURGEON REMOVED THE LEFT DRAIN WITHOUT RESISTANCE AND IT WAS NOTED TO BE INTACT. DURING REMOVAL OF THE RIGHT DRAIN THE SURGEON NOTED THAT THERE WAS NO RESISTANCE, BUT THAT THE DRAIN WAS TEARING AT ONE OF THE PERFORATIONS. THE SURGEON ATTEMPTED TO GRAB THE DRAIN PIECE THAT WAS TEARING WITH A HEMOSTAT TO ENSURE ENTIRE REMOVAL, BUT THIS WAS TO UNCOMFORTABLE FOR THE PATIENT. A DECISION WAS MADE TO CUT THE DRAIN AND RETURN THE PATIENT FOR SURGICAL REMOVAL OF THE RETAINED DRAIN PIECE. THE PATIENT WAS BROUGHT BACK TO SURGERY WHERE THE INCISION WAS RE-OPENED AND THE ENTIRE DRAIN WAS REMOVED AND EXAMINED. THERE WAS AN OBVIOUS FRACTURE THROUGH THE PERFORATION AT THE PROXIMAL END OF THE DRAIN. THE PATIENT RECOVERED WITHOUT INCIDENT. NO PERMANENT HARM TO THE PATIENT. THE SURGEON IMMEDIATELY STOPPED USING THE

  Patient problems: Discomfort

  MAUDE report 8170882 ↗
• MalfunctionJul 25, 2018Break

  THE DRAIN BROKE WHILE IT WAS BEING REMOVED AND A FOLLOW-UP X-RAY REVEALED A 4CM PIECE OF RESIDUAL DRAIN CATHETER REMAINED IN THE RIGHT SUBCUTANEOUS TISSUE. THE EXTERNAL PORTION OF THE DRAIN WAS DISCARDED. AS OF (B)(6) 2018 THE BROKEN PIECE REMAINS IN THE PATIENT, AND OVERALL THE PATIENT IS DOING WELL. AN ADDITIONAL PROCEDURE WILL BE NEEDED TO REMOVE THE BROKEN PIECE LATER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7721121 ↗