MEDLINE EBSI1789ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160387886), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 16, 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.

• MalfunctionMar 25, 2026Crack; Material Fragmentation

  IT WAS REPORTED THAT "THE SYRINGE CRACKED AT THE HUB CONNECTION SITE" AFTER "FLUSHING THE PATIENT'S IV LINE USING A PREFILLED SYRINGE SUPPLIED IN THE PORT ACCESS KIT." THE CUSTOMER REPORTED THAT THEY "ATTACHED A NEW PREFILLED SYRINGE FROM THE SAME KIT TO CONTINUE FLUSHING THE LINE" AND THAT "AFTER COMPLETING THE FLUSH AND REMOVING THE SECOND SYRINGE, THAT SYRINGE ALSO CRACKED AT THE HUB CONNECTION SITE." THE CUSTOMER STATED, "A SMALL FRAGMENT OF PLASTIC FROM THE SYRINGE TIP HAD REMAINED WITHIN THE IV HUB" WHICH "COMPROMISED THE INTEGRITY OF THE CONNECTION, ALLOWING BLOOD BACKFLOW FROM THE PATIENT'S IV LINE." PER THE CUSTOMER, THE "ENTIRE IV LINE WAS REMOVED AND A NEW LINE WAS INITIATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690586 ↗