CARDINAL HEALTH SAN11CPJSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439349597), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT THE BLUE COTTON OR TOWELS PWTB03-STM FROM THE CATHETERIZATION PACK SAN11CPJSB WERE LINTING. NO INJURY WAS REPORTED. NO FURTHER DETAILS OF THE CASE OR PATIENT DEMOGRAPHICS WERE PROVIDED BY THE CUSTOMER AFTER NUMEROUS ATTEMPTS TO RETRIEVE. MDR BEING FILED FOR MALFUNCTION AND POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193444 ↗