CARDINAL HEALTH SU130-1361Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885380061530), received between Dec 22, 2017 and Nov 24, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2020Break; Use of Device Problem; Use of Device Problem

  CUSTOMER REPORTED THAT WHILE REMOVING THE KIT DRAIN 100CC W/10MM PERF/ SU130-1361 FROM THE PATIENT'S SHOULDER/NECK, THE TUBING BROKE AT THE INSERTION SITE. ENTIRE REST OF THE TUBING REMAINED IN THE PATIENT WITH NOTHING PROTRUDING TO PULL OUT. DOCTOR HAD TO REMOVE THE TUBING THROUGH EXISTING INCISION WITH FORCEPS. THE REMAINING PIECE WAS RETRIEVED. NO FURTHER ISSUE WITH PATIENT WAS REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER MULTIPLE ATTEMPTS TO RETRIEVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10890283 ↗
• InjuryJul 24, 2020Break; Difficult to Remove; Difficult to Remove

  BASED ON INFORMATION RECEIVED ALLEGEDLY THE CLEAR PLASTIC TUBING BROKE DURING REMOVAL FROM A PATIENT RESULTING IN 20CM OF DRAIN BEING LEFT IN THE PATIENT. THE DRAIN WAS PLACED ON (B)(6) 2020 AND REPORTEDLY BROKE ON ATTEMPTED REMOVAL ON (B)(6) 2020. REPORTEDLY THE FOREIGN BODY WAS REMOVED ON (B)(6) 2020. THE INITIAL INCISION WAS RE-OPENED, AND THE DRAIN PALPATED THEN REMOVED. REPORTEDLY THE PATIENT WAS ON ERTAPENEM 1G IV DAILY FROM (B)(6) 2020. CLOXACILLIN 2G IV Q6H (B)(6) 2020. TAZOCIN 3.375G IV Q6H (B)(6) 2020. ON (B)(6) 2020 HE HAD TO RETURN TO THE OR FOR ANOTHER SURGICAL PROCEDURE AND IS CURRENTLY ON CLINDAMYCIN 900MG Q8H, VANCOMYCIN 1.5G IV Q8H, AND PIPTAZ 4.5G IV Q6H.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 10319648 ↗
• MalfunctionApr 13, 2018Break; Detachment Of Device Component

  PHYSICIAN ATTEMPTED TO REMOVE THE JACKSON PRATT DRAIN DRAIN FROM THE PATIENT, BUT A PIECE SNAPPED OFF INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430036 ↗
• MalfunctionDec 22, 2017Break

  CLINICIAN CLAIMS WHILE REMOVING DRAINAGE JP 10X20 FLAT ON THE 7TH DAY POST OPERATIVE FROM THE PATIENT CAVITY, IT BROKE LEAVING BEHIND FLAT DRAIN PIECE INSIDE THE PATIENT. THE PATIENT HAD TO BE RUSHED TO THE OPERATING ROOM TO REMOVE THE PIECE OF DRAIN. THE LOT WAS NOT AVAILABLE.

  Patient problems: No Information

  MAUDE report 7141711 ↗