BD Integra 305312Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903053124), received between Aug 2, 2019 and Jul 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT 2 NEEDLE INTEGRA 23X1 RB TW EXPERIENCED PREMATURE NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN SOME CONCERNS REPORTED WITH EARLY RETRACTION OF THE NEEDLE. SUSPECTED USER ERROR BY REPORTING CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229842 ↗
• MalfunctionAug 2, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED AT A UNSPECIFIED TIME WITH A BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CLINICAL EVENT INFORMATION: MEDICATION LEAKING OUT OF DEVICE WHILE IN USE. PATIENT OUTCOME/CONSEQUENCES: LOSS OF MEDICATION / NOT ADMINISTERED TO PATIENT DUE TO FAULT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8857474 ↗