CARDINAL HEALTH SU130-1320Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10192253022391), received between Aug 24, 2021 and Mar 3, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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 12 most recent of 12 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. THE 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 24501561 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331155 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331151 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331140 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331136 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331103 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331102 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331086 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331082 ↗
• MalfunctionOct 17, 2025Material Separation; Material Separation

  CUSTOMER REPORTED THAT THE DRAIN FROM PACK BROKE AND SNAPPED INTO TWO PIECES, BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331050 ↗
• InjuryMay 21, 2025Break; Break

  CUSTOMER REPORTED THAT DRAINS WERE INITIALLY REMOVED WITHOUT ANY CONCERN IN THE ENT CLINIC. A 7MM RETAINED PIECE OF JACKSON PRATT DRAIN WAS NOTED AND REMOVED AFTER DISCOVERED INTRAOPERATIVELY DURING A SURGERY. THE PIECE WAS REMOVED ENDOSCOPICALLY, REMOVAL CONFIRMED BY X-RAY, AND TUBING SENT TO PATHOLOGY. CT SCAN TO BE GIVEN TO ENSURE NO FURTHER SMALL FRAGMENTS AND IF THERE ARE, WILL BE ABLE TO REMOVE WITH NEXT SURGERY. THE CLIENT AND CONTACT INFORMATION IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22064325 ↗
• InjuryAug 24, 2021Break; Break

  PATIENT WAS WITH SEVERE STENOSIS AT THE L4-5 SEGMENT IN THE SETTING OF SPONDYLOLISTHESIS AS WELL AS OSTEOPOROSIS. WENT TO THE OR FOR SPINOUS PROCESS-SPLITTING LAMINOPLASTY OF L4, DECOMPRESSION OF THE L4-5 INTERSPACE WITH PARTIAL MEDIAL FACETECTOMY BILATERALLY, L5-S1 FORAMINOTOMIES BILATERALLY, AND REPAIR OF DURAL DEFICIENCY OVER THE RIGHT SIDE OF THE L4-5 LATERAL RECESS UTILIZING 6-0 GORE-TEX SUTURE AND DURASEAL SEALANT. A CLOSED SUCTION DRAIN WAS INSERTED. THE NEXT DAY, SURGICAL DRAIN WAS REMOVED AT THE BEDSIDE THAT MORNING. AFTER REMOVAL, REPORTEDLY THERE WERE ONLY TWO FENESTRATIONS IN THE END OF THE DRAIN VISUALIZED. THE PATIENT WAS TAKEN TO THE OR AND PREVIOUS SUTURES WERE REMOVED. DEEP DERMAL SUTURES WERE ALSO REMOVED BRING THE FASCIA INTO VIEW. THE FASCIAL LAYER REMAINED NICELY APPROXIMATED AND CLOSED. IN THE DISTAL ASPECT OF THE PREVIOUS FASCIAL OPENING, THE REMAINING DRAIN FRAGMENT WAS EASILY IDENTIFIED. THIS WAS SUCCESSFULLY REMOVED WHOLE WITH THE ASSISTANCE OF A NEEDLE DRIVER. THE WOUND WAS INSPECTED AND COPIOUSLY IRRIGATED WITH STERILE SALINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12363241 ↗