BD Integra 305313Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903053131), received between Oct 17, 2017 and Sep 30, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE NEEDLE INTEGRA 22X1-1/2 RB TW EXPERIENCED A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSING STAFF HAVE REPORTED A MALFUNCTION WITH A BD SYRINGE/NEEDLE ON (B)(6) 2021. THERE WAS A MALFUNCTION WITH THE NEEDLE AND IT FAILED TO RETRACT. NO HARM TO PATIENT DUE TO MALFUNCTION. DUE TO THE NATURE OF THE MALFUNCTION OF THE SYRINGE AND NEEDLE IT APPEARED THAT APPROXIMATELY 0.1 ML TO 0.2 ML OF LAI FAILED TO BE ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555234 ↗
• InjuryDec 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE INTEGRA 22X1-1/2 RB TW LEAKED DURING A "LONG ACTING DEEP INTRAMUSCULAR INJECTION", CAUSING AN UNDERDOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "T2 FAILURES IN 7 DAYS, LEAKAGE OF OIL BASED LONG ACTING DEEP INTRAMUSCULAR INJECTION. THIS CAUSED REDUCED MEDICATION DOSAGE ADMINISTRATION."

  Patient problems: Underdose

  MAUDE report 11032886 ↗
• MalfunctionApr 23, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A NEEDLE INTEGRA 22X1-1/2 RB TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT CUSTOMER HEARD A POPPING SOUND AFTER DELIVERING MEDICATION, HOWEVER THE NEEDLE WAS STILL EXPOSED. CUSTOMER CALLED AND REPORTED "NEEDLE FAILED TO RETRACT , A POPPING SOUND WAS HEARD AFTER MEDICATION DELIVERY BUT THE NEEDLE WAS STILL EXPOSED" LOT 9329611."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9991966 ↗
• MalfunctionApr 26, 2019Retraction Problem

  IT WAS REPORTED THAT AFTER USE OF THE 22 G X 1 1/2 IN. BD INTEGRA¿ NEEDLE THE NEEDLE FAILED TO RETRACT POST IM INJECTION LEAVING EXPOSED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE FAILED TO RETRACT POST IM INJECTION LEAVING EXPOSED NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8558014 ↗
• MalfunctionOct 17, 2017Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CONNECTION OF THE 22 G X 1 1/2 IN. BD INTEGRA" NEEDLE AND THE SYRINGE WERE LOOSE CAUSING THE FLUID TO LEAK. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956157 ↗