CARDINAL HEALTH SU130-1311 (UDI 10885380064036)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885380064036), received between Dec 9, 2016 and Apr 13, 2020 — classified as 2 injuries, 4 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2020Fracture

  MEDWATCH REPORT MW5093398 RECEIVED STATING (B)(6) UNDERWENT PARTIAL NEPHRECTOMY. A JACKSON PRATT DRAIN WAS PLACED AT THE TIME ON (B)(6). DURING BEDSIDE JP DRAIN REMOVAL ON (B)(6), DRAIN FRACTURED AND A PIECE WAS RETAINED. PATIENT REQUIRED ADDITIONAL PROCEDURE TO REMOVE RETAINED PIECE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9955663 ↗
• MalfunctionNov 3, 2019Break

  DRAIN PLACED AT TIME OF SURGERY IN 2018. DRAIN BROKE UPON REMOVAL IN CLINIC ON (B)(6) 2018 AND NOT IDENTIFIED UNTIL CT PERFORMED ON UNKNOWN DATE IN 2019.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9270605 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT DURING A HERNIA PROCEDURE WITH A MINI ABDOMINAL PLASTI, WOUND DRAIN WAS PLACED IN PATIENT. IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AND THE DRAIN WAS PULLED. CUSTOMER FURTHER REPORTED THEY HAVE NEVER HAD INFECTIONS AND ARE NOT CERTAIN IF DRAIN IS THE CAUSE FOR THIS PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 6777943 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT DURING PROCEDURE WOUND DRAIN WAS PLACED IN PATIENT FOLLOWING THE REMOVAL OF A LARGE LESION FROM ABDOMEN. IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AND THE DRAIN WAS PULLED. CUSTOMER FURTHER REPORTED THEY HAVE NEVER HAD INFECTIONS AND ARE NOT CERTAIN IF DRAIN IS THE CAUSE FOR THIS PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 6777412 ↗
• MalfunctionMay 23, 2017Break

  WHEN THE RESIDENT WAS REMOVING THE DRAIN FROM THE PATIENT IT SNAPPED OFF IN THE PATIENT¿S PELVIS. THE TEAM HAD TO GO BACK IN TO REMOVE THE DRAIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6586116 ↗
• MalfunctionDec 9, 2016Material Fragmentation; Device Dislodged or Dislocated; Noise, Audible

  (B)(4): A JACKSON-PRATT (JP) DRAIN BROKE DURING REMOVAL FROM A PATIENT. THE PHYSICIAN STATES THAT THE PATIENT HAD A SHORT/THICK NECK AND WHEN HE WAS PULLING THE CATHETER OUT, HE FELT A "SNAP" AND THE DRAIN CAME OUT WITH PIECES MISSING. ALL MISSING PIECES FROM JP DRAIN, WERE LOCATED AND REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6159540 ↗