CARDINAL HEALTH SU130-1305 (UDI 10885380061493)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885380061493), received between Oct 19, 2016 and Jun 27, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Material Frayed

  JP DRAIN FRAYED WHILE BEING REMOVED FROM THE PATIENT'S HEAD. THERE WERE NO RETAINED OBJECTS IN THE PATIENT'S HEAD WHEN THE PHYSICIAN TOOK THE PATIENT BACK TO SURGERY. PATIENT HAS NO INFECTIOUS DISEASES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8742052 ↗
• MalfunctionJan 3, 2019Suction Problem; Gas/Air Leak

  WE HAVE HAD SUCTIONING ISSUES WITH THE BULB. ONE PATIENT THAT ENDED UP WITH FREE AIR IN THE ABDOMEN WAS RETURNED TO SURGERY ABOUT 12 HOURS AFTER THE SURGICAL PROCEDURE, BUT IS FINE NOW. THE FREE AIR IN THE ABDOMEN WAS CONFIRMED BY XRAY AND CT SCAN. I AM NOT SURE IF IT IS A NURSING ERROR OR THE BULBS THEMSELVES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8211919 ↗
• MalfunctionFeb 16, 2018Detachment Of Device Component; Device Operates Differently Than Expected

  CUSTOMER HAS REPORTED THAT IN A SEVERE CASE, A RHYTIDECTOMY PATIENT RETURNED TO OUR OFFICE FOR HER POSTOPERATIVE APPOINTMENT ON THE DAY AFTER HER SURGERY. HER DRAIN BALL WAS ROUND, THE PLUG WAS OUT AND HER FACE WAS SO SWOLLEN WITH FLUID ON THE RIGHT SIDE. PATIENT REQUIRED GENERAL ANESTHESIA TO OPEN THAT SIDE OF HER FACE AGAIN AND REMOVE THE COLLECTED FLUID THAT WAS NOT REMOVED BY THE DRAIN DUE TO THE PLUG IN THE RESERVOIR HAD REPORTEDLY COME OUT TOO EASILY.

  Patient problems: Edema; Swelling

  MAUDE report 7277328 ↗
• InjuryAug 16, 2017Fluid/Blood Leak; Suction Problem

  RECEIVED COMPLAINT THAT REPORTED PLUG FAILURES WITH THE JACKSON PRATT BULB RESERVOIR. THE REPORT STATED THAT THE PLUG PORT BECOMES ENLARGED CAUSING BOTH BODILY FLUID LEAKAGE AND LACK OF SUCTION INCREASING ISSUES WITH ABDOMINAL FLUID RETENTION.

  Patient problems: Edema

  MAUDE report 6797584 ↗
• MalfunctionOct 19, 2016Backflow

  CUSTOMER REPORTS THE BLOOD IS RE-FLEXING BACK UP, MAKING AN AIR TO STRIKE INTO THE SUCTION BULB AND PATIENT'S HEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6042334 ↗