BD Integra 305311Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903053117), received between Oct 17, 2017 and Jun 23, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2024Retraction Problem; Retraction Problem

  MATERIAL# 305311 BATCH# 1172469 IT WAS REPORTED THAT THE BD NEEDLE INTEGRA 25X1 RB TW HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HI, WE HAVE HAD AN ISSUE WITH A 1" RETRACTABLE NEEDLES. THE FIRST IS THAT THE NEEDLE WAS NOT CAPPED WHILE THE PACKAGING WAS STILL SEALED SECOND IS THAT THE NEEDLE DID NOT RETRACT AFTER A VACCINE WAS ADMINISTERED AND THE MA TRIED TO ENGAGE THE SAFETY DATE OCCURRED: THURSDAY ON (B)(6)2024 NO INJURY. BOTH NEEDLE ISSUES WERE FROM THE SAME LOT NUMBER BOTH ARE LOT # 1172469 EXP: 12-31-26 CUSTOMER WOULD LIKE CREDIT FOR 1 BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591572 ↗
• MalfunctionJan 20, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD INTEGRA RETRACTING NEEDLE THE NEEDLE PULLED FREE FROM THE HUB DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THE RETRACTABLE NEEDLE HAD STAYED IN THE PATIENTS ARM NO MEDICAL ATTENTION NEEDED AS THEY WERE ABLE TO REMOVE WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213410 ↗
• MalfunctionSep 24, 2022Break; Break

  IT WAS REPORTED THAT THE BD INTEGRA¿ NEEDLE DISCONNECTED FROM HUB CAUSING THE NEEDLE TO FAIL RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INTEGRA NEEDLE IS NOT RETRACTING COMPLETELY. NEEDLE STAYED IN PATIENT AND DISCONNECTED FROM HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477658 ↗
• MalfunctionDec 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INTEGRA¿ NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER ACCOUNT, WE ARE HAVING TROUBLE WITH THE SYRINGES/NEEDLES AS THEY ARE HAVING RARE LEAKS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005826 ↗
• MalfunctionJul 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED SEVERAL NEEDLE INTEGRA 25X1 RB TW HAD ITS NEEDLE DETACH 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 12252521 ↗
• MalfunctionMar 10, 2021Break; Leak/Splash; Break; Leak/Splash

  IT REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE INTEGRA 25X1 RB TW WERE DAMAGED/DEFECTED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING SOME MALFUNCTION WITH INTEGRA NEEDLES.  VERBATIM:...A NURSE FOR SUTTER HEALTH INTERNAL MEDICINE DEPARTMENT. I JUST WANT TO REPORT SOME MALFUNCTION BD INTEGRA NEEDLES. BELOW IS THE BRAND NAME AND BADGE OR REFERENCE NUMBER. BD INTEGRA RETRACTING NEEDLE REF: 305311."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457621 ↗
• MalfunctionOct 28, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT NEEDLE INTEGRA 25X1 RB TW WAS NOT STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURRED AFTER A NEEDLE WAS NOT CAPPED WITHIN PACKAGING. VERBATIM - PER CUSTOMER: I WANTED TO ALERT YOU TO AN ISSUE WITH OUR INTEGRA NEEDLES. WE HAD NO SEPARATE BOXES, ONE WITH 1 INCH AND ONE WITH 5/8INCH REPLACEMENT NEEDLES. THEY WERE OUT OF THE SAFETY CAP AND SOMEONE HERE GOT STUCK WITH IT. I WROTE DOWN THE LOT NUMBER FOR YOU. I DID CHECK EVERYTHING IN THE DRAWS AND WENT THROUGH BOXES AND PUT SAFETY CHECKS ON THE BOXES I WENT THROUGH BUT I WANTED TO ALERT YOU TO THIS. I HAVE THE NEEDLES AND I CAN SEND YOU A PICTURE. MCKESSON REP STATED THAT NEEDLE WAS NOT CAPPED IN PACKAGE AND WAS STICKING OUT THROUGH WRAPPER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751997 ↗
• MalfunctionJun 20, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE BD INTEGRA¿ NEEDLE WOULDN'T RETRACT DURING USE AFTER REMOVING IT FROM THE PATIENT. LOT #'S 6139911 AND 6299679 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE IS NOT RETRACTING AFTER WITHDRAWING FROM THE PATIENT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716468 ↗
• MalfunctionAug 24, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT BEFORE USE OF THE BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE "THE PROTECTIVE CAP HAS BECOME DISLODGED FROM THE NEEDLE INSIDE THE PACKAGE AND THE NEEDLE IS PROTRUDING THROUGH THE OUTSIDE PLASTIC WRAPPER". THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813845 ↗
• MalfunctionJul 17, 2018Leak/Splash

  IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE "LEAKED AND DIDN'T RETRACT". NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694571 ↗
• MalfunctionMay 8, 2018Leak/Splash

  IT WAS REPORTED THAT DURING CLIENT INJECTION, THE VACCINE LEAKED OUT BETWEEN THE SYRINGE AND THE NEEDLE OF THE BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE. THE CLIENT NEEDED TO BE INJECTED AN EXTRA TIME. FOUND DURING USE. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494154 ↗
• MalfunctionMay 7, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE RETRACTING NEEDLE LEAKED VACCINES OUT BETWEEN THE SYRINGE AND THE NEEDLE. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492891 ↗
• MalfunctionJan 25, 2018Packaging Problem

  PRIOR TO DRAWING UP VACCINES, THE MEDICAL ASSISTANT NOTICED THAT THIS NEEDLE WAS NOT CAPPED IN IT'S ORIGINAL PACKAGING. NO INJURIES NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221773 ↗
• MalfunctionDec 21, 2017Leak/Splash

  IT WAS REPORTED THAT DURING USE A LEAK WAS OBSERVED FROM THE BD INTEGRA¿ NEEDLE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140528 ↗
• MalfunctionDec 18, 2017Leak/Splash

  IT WAS REPORTED THAT DURING USE, A BD INTEGRA¿ SYRINGE RETRACTING NEEDLE LEAKED OUT MEDICATION ON THE PATIENT¿S ARM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: Chemical Exposure

  MAUDE report 7124326 ↗
• MalfunctionOct 17, 2017Leak/Splash

  IT WAS REPORTED THAT A BD INTEGRA¿ SYRINGE, 25 G X 1 IN RETRACTING NEEDLE WAS FOUND LEAKING DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956190 ↗