BD Integra 305310Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903053100), received between Oct 23, 2017 and Feb 28, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED BD INTEGRA¿ NEEDLE 25X5/8 HAD THE NEEDLE BREAK OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE REMOVED FROM THE CHILDS THIGH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620392 ↗
• InjuryFeb 1, 2022Break; Break

  IT WAS REPORTED THAT BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE HAD THE NEEDLE BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " BD1-A NURSE AT (B)(6) WHILE ADMINISTRATING AT SHOT TO ON A CHILD THE NEEDLE BROKE OFF IN THE CHILD'S LEG."

  Patient problems: Foreign Body In Patient

  MAUDE report 13415533 ↗
• MalfunctionJul 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED MULTIPLE NEEDLE INTEGRA 25X5/8 RB TW HAD NEEDLES DETACHING FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE ARE LOOSE UNUSED SAMPLES AND APPROXIMATELY 100 SAMPLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250018 ↗
• MalfunctionDec 18, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE INTEGRA 25X5/8 RB TW EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305310 BATCH NO.: 7263635. PER EMAIL PIR: SYRINGE IS LEAKING FLUID WHEN CORRECT NEEDLE IS PLACED ON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9490713 ↗
• MalfunctionMar 27, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT A NEEDLE INTEGRA 25X5/8 RB TW HAD LEAKAGE. THE FOLLOWING WAS REPORTED, "MATERIAL NO. 305310 .BATCH NO. 7027897. IT WAS REPORTED THERE WAS LEAKAGE. "ADMINISTERED MMR VACCINE WITH BD INTEGRA 3ML SYRINGE AND BD INTEGRA RETRACTING NEEDLE COMBO. WHEN ADMINISTERING MMR ON THE RIGHT THIGH, THE VACCINE LIQUID LEAKED FROM THE HUB OF THE NEEDLE. THE NEEDLE WAS PROPERLY SCREWED ON AND FULLY INSERTED INTO THE SUBCUTANEOUS TISSUE OF THE THIGH. UNABLE TO VERIFY HOW MUCH VACCINE WAS ADMINISTERED INTO THE PATIENT. PER RN THE PATIENT WILL NEED TO REPEAT THE MMR VACCINE IN ORDER TO ENSURE THE CHILD RECEIVED THE PROPER DOSE OF MMR."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457927 ↗
• MalfunctionDec 10, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ SYRINGE, 25 G X 5/8 INCH RETRACTING NEEDLES THE MEDICATION LEAKED OUT OF THE SYRINGE DURING ADMINISTRATION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8147614 ↗
• MalfunctionAug 20, 2018Leak/Splash

  IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE, 25 G X 5/8 INCH RETRACTING NEEDLES ARE LEAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7799384 ↗
• MalfunctionJan 12, 2018Retraction Problem

  IT WAS REPORTED AFTER ADMINISTERING VACCINATIONS USING AN BD INTEGRA¿ SYRINGE, 25 G X 5/8 IN RETRACTING NEEDLE, THE NEEDLE FAILED TO RETRACT WHEN THE PLUNGER WAS PUSHED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185807 ↗
• MalfunctionDec 18, 2017Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE A BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE WAS FOUND WITH BLACK PARTICLES ON THE NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7125897 ↗
• MalfunctionNov 30, 2017Retraction Problem; Scratched Material

  IT WAS REPORTED THAT AFTER USE, A BD INTEGRA¿ SYRINGE WITH RETRACTING NEEDLE DID NOT RETRACT COMPLETELY WHICH RESULTED IN A PATIENT RECEIVING A SUPERFICIAL SCRATCH ON HER THIGH WHEN THE SYRINGE WAS BEING PULLED AWAY. THE TIP OF THE NEEDLE WAS STILL OUTSIDE THE HUB OF THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7070416 ↗
• MalfunctionOct 23, 2017Leak/Splash

  IT WAS REPORTED THAT WHILE DRAWING UP VACCINE USING A BD INTEGRA¿ SYRINGE, 25 G X 5/8 IN RETRACTING NEEDLE, THE DEVICE LEAKED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6969418 ↗