BD Integra 305269Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00382903052691), received between Oct 17, 2017 and Oct 15, 2025 — classified as 9 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (39 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. 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305269 BATCH#: 2307009. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT WHEN THEY WENT TO GIVE 2 PATIENTS MEDICATION, THE MEDICATION SHOT OUT THE SIDE WHERE THE NEEDLE CONNECTS TO THE SYRINGE. BOTH INSTANCES HAPPENED TODAY 23SEP2025. PATIENTS HAD TO BE RE-ADMINISTERED MEDICATION SINCE THEY DID NOT RECEIVE IT THE FIRST TIME. REF#: 305269 LOT #: 2307009. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285602 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305269 BATCH#: 2307009. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT WHEN THEY WENT TO GIVE 2 PATIENTS MEDICATION, THE MEDICATION SHOT OUT THE SIDE WHERE THE NEEDLE CONNECTS TO THE SYRINGE. BOTH INSTANCES HAPPENED TODAY (B)(6) 2025. PATIENTS HAD TO BE RE-ADMINISTERED MEDICATION SINCE THEY DID NOT RECEIVE IT THE FIRST TIME. REF#: 305269, LOT #: 2307009. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285189 ↗
• MalfunctionJul 11, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB NEEDLE RETRACTED PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305269 BATCH#: 1270380. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCTCOMPLAINT REF 305269 LOT 1270380 ISSUE: RN WHILE INJECTING VACCINE SYRINGE RETRACTED WHILE THERE WAS STILL ADMINISTERING. PREMATURE RETRACTION. DOE 27JUNE2025. SECOND INCIDENT SAME PREMATURE RETRACTION, CUSTOMER SAID SAME LOT. DOE: 27MAY2025. ADDITIONAL INFO: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. TOTAL NUMBER OF OCCURRENCES? 3 WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO, THE NEEDLE RETRACTED DURING ADMINISTRATION. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? NO, FASTER THAN NORMAL DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED ? YES, AND THIS TOOK PLACE DURING ADMINISTRATION DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? THE BUTTON WAS NOT PRESSED AT ALL DID THE BUTTON DEPRESS? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487645 ↗
• MalfunctionJul 11, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB NEEDLE RETRACED PREMATURELY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305269, BATCH#: 1270380. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCTCOMPLAINT: REF 305269, LOT 1270380. ISSUE: RN WHILE INJECTING VACCINE SYRINGE RETRACTED WHILE THERE WAS STILL ADMINISTERING. PREMATURE RETRACTION. DOE (B)(6) 2025. SECOND INCIDENT SAME PREMATURE RETRACTION, CUSTOMER SAID SAME LOT. DOE: 27MAY2025. ADDITIONAL INFO: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. TOTAL NUMBER OF OCCURRENCES? 3. WHEN YOU PRESSED THE BUTTON, DID THE NEEDLE FULLY RETRACT? NO, THE NEEDLE RETRACTED DURING ADMINISTRATION. DID THE NEEDLE RETRACT SLOWER THAN NORMAL? NO, FASTER THAN NORMAL. DID THE NEEDLE START RETRACTING AND THEN STOP, LEAVING THE NEEDLE EXPOSED ? YES, AND THIS TOOK PLACE DURING ADMINISTRATION. DID THE NEEDLE NOT MOVE AT ALL AFTER PRESSING THE BUTTON? THE BUTTON WAS NOT PRESSED AT ALL DID THE BUTTON DEPRESS? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487640 ↗
• MalfunctionMay 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE/NEEDLE COMBINATION LEAKED. DISCOVERED BY: SITE NURSE. DATE OF DISCOVERY: (B)(6) 2025. DATE OF OCCURRENCE: (B)(6) 2025. ITEM NUMBER: 305269. LOT NUMBER: 0259746. WHEN THE STUDY DRUG WAS BEING ADMINISTERED, THE NURSE NOTICED SOME DROPS OF THE STUDY DRUG HAD LEAKED OUT. ADMINISTRATION WAS STOPPED AND THE NEEDLE/SYRINGE WAS ASSESSED. THE NEEDLE OF THE SYRINGE WAS REPLACED AND THE REMAINDER OF THE STUDY DRUG (0.7 ML) WAS ADMINISTERED WITHOUT ISSUE. THE TOTAL VOLUME OF STUDY DRUG AT THE BEGINNING WAS 1.6ML BUT IT IS UNCLEAR HOW MUCH HAD LEAKED; THEREFORE, IT IS UNKNOWN HOW MUCH OF THE STUDY DRUG WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057107 ↗
• MalfunctionDec 19, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20977486 ↗
• MalfunctionDec 19, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20977145 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466402 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348851 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348723 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347690 ↗
• MalfunctionSep 24, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 305269. BATCH NUMBER#: 3234572. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: THE ED REPORTED AN ISSUE THEY HAD WITH A 3ML INTEGRA SYRINGE WHICH I¿M MAKING YOU AWARE OF. IT¿S DIFFICULT TO SAY EXACTLY HOW THIS HAPPENED AND WHETHER IT WAS USER ERROR, BUT AM REPORTING IT TO YOU IN CASE THERE ARE ANY FURTHER INCIDENTS HERE. SHE SAID ¿THE RN ATTEMPTED TO ADMINISTER AN IM MEDICATION. UPON ADMINISTRATION, MEDICATION NOTED TO LEAK OUT OF SYRINGE. WHEN THE RN PRESSED TO RETRACT NEEDLE INTO DEVICE FOR SAFETY, PIECES OF NEEDLE DEVICE DISLODGED ACROSS ROOM (SPRING AND PLASTIC NEEDLE CAP). RESOURCE AND MD MADE AWARE AND PROVIDED PACKAGE AND PIECES.¿ NO INJURY TO PATIENT. ADDITIONAL INFORMATION PROVIDED: 1. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. ¿ NO PHOTO AVAILABLE 2. CAN YOU PLEASE SHARE THE EXACT LOCATION OF THE LEAK ¿ THE MEDICATION LEAKED OUT OF THE SYRINGE PER THE RN. SHE DID NOT PROVIDE FURTHER DETAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296814 ↗
• MalfunctionSep 24, 2024Retraction Problem; Retraction Problem

  MATERIAL#: 305269, BATCH NUMBER#: 3234572. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB HAD A NEEDLE RETRACTION FAILURE (INTEGRA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ED REPORTED AN ISSUE THEY HAD WITH A 3ML INTEGRA SYRINGE WHICH I¿M MAKING YOU AWARE OF. IT¿S DIFFICULT TO SAY EXACTLY HOW THIS HAPPENED AND WHETHER IT WAS USER ERROR, BUT AM REPORTING IT TO YOU IN CASE THERE ARE ANY FURTHER INCIDENTS HERE. SHE SAID ¿THE RN ATTEMPTED TO ADMINISTER AN IM MEDICATION. UPON ADMINISTRATION, MEDICATION NOTED TO LEAK OUT OF SYRINGE. WHEN THE RN PRESSED TO RETRACT NEEDLE INTO DEVICE FOR SAFETY, PIECES OF NEEDLE DEVICE DISLODGED ACROSS ROOM (SPRING AND PLASTIC NEEDLE CAP). RESOURCE AND MD MADE AWARE AND PROVIDED PACKAGE AND PIECES.¿ NO INJURY TO PATIENT. ADDITIONAL INFORMATION PROVIDED: 1. PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. ¿ NO PHOTO AVAILABLE. 2. CAN YOU PLEASE SHARE THE EXACT LOCATION OF THE LEAK ¿ THE MEDICATION LEAKED OUT OF THE SYRINGE PER THE RN. SHE DID NOT PROVIDE FURTHER DETAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296288 ↗
• MalfunctionJun 19, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570925 ↗
• MalfunctionJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL # 305269. LOT # 3234572, 3256108. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECENTLY, WHILE ATTEMPTING TO ADMINISTER INJECTIONS USING BD ITEM #305269, OUR END-USERS HAVE ENCOUNTERED A RECURRING PROBLEM WHERE THE NEEDLE SEPARATES FROM THE SYRINGE DURING THE PROCESS. THIS HAS BEEN BOTH FRUSTRATING AND CONCERNING FOR OUR STAFF AS IT COULD COMPROMISE THE SAFETY AND EFFECTIVENESS OF THE PROCEDURE. WE WOULD GREATLY APPRECIATE IT IF YOU COULD LOOK INTO THIS MATTER AND PROVIDE US WITH ANY INSIGHTS OR SUGGESTIONS ON HOW TO ADDRESS THIS ISSUE."

  Patient problems: Insufficient Information

  MAUDE report 19506716 ↗
• MalfunctionSep 20, 2023Complete Blockage; Defective Component; Complete Blockage; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786398 ↗
• MalfunctionJul 28, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING USE WITH BD INTEGRA 3ML SYRINGE THE NEEDLE RETRACTED PREMATURELY. THERE WAS NO PATIENT IMPACT. 2 OF 2 REPORTS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE BELIEVES THERE WAS AN ISSUE WITH THE SYRINGE NEEDLE CAP, UNSURE IF THE NEEDLE PREMATURELY RETRACTED. THE PATIENT DID NOT EXPERIENCE ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412915 ↗
• MalfunctionJul 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD INTEGRA 3ML SYRINGE LEAKAGE OCCURRED. 1 OF 2 REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER A SYRINGE MALFUNCTION OCCURRED, AND THE DRUG SPILLED OUT FROM THE TIP OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412910 ↗
• MalfunctionJul 27, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE NEEDLE PREMATURELY RETRACTED. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE PATIENT PRESENTED TO CLINIC ON (B)(6) 2023 FOR C4D1 OF 3,000MCG/KG DOSE. DOSE WAS SPLIT INTO 2 SEPARATE SYRINGES FOR A TOTAL VOLUME OF 2.1ML. THE 1ST INJECTION WAS ADMINISTERED WITHOUT ANY INCIDENT. THE 2ND INJECTION, A SYRINGE MALFUNCTION OCCURRED AND THE DRUG SPILLED OUT FROM THE TIP OF THE SYRINGE. THE NURSE BELIEVE THERE WAS AN ISSUE WITH THE SYRINGE NEEDLE CAP, UNSURE IF THE NEEDLE PREMATURELY RETRACTED. THE PATIENT DID NOT EXPERIENCED ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410262 ↗
• MalfunctionJul 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE THE DRUG SPILLED OUT FROM THE TIP. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INTIIAL REPORTER: VERBATIM: PRESENTED TO CLINIC ON 21JUN23 FOR C4D1 OF 3,000MCG/KG DOSE. DOSE WAS SPLIT INTO 2 SEPARATE SYRINGES FOR A TOTAL VOLUME OF 2.1ML. THE 1ST INJECTION WAS ADMINISTERED WITHOUT ANY INCIDENT. THE 2ND INJECTION, A SYRINGE MALFUNCTION OCCURRED AND THE DRUG SPILLED OUT FROM THE TIP OF THE SYRINGE. THE NURSE BELIEVE THERE WAS AN ISSUE WITH THE SYRINGE NEEDLE CAP, UNSURE IF THE NEEDLE PREMATURELY RETRACTED. THE PATIENT DID NOT EXPERIENCED ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410259 ↗
• MalfunctionJul 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE MALFUNCTION OCCURRED, AND THE DRUG SPILLED OUT FROM THE TIP OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396141 ↗
• MalfunctionJul 26, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE BELIEVES THERE WAS AN ISSUE WITH THE SYRINGE NEEDLE CAP, UNSURE IF THE NEEDLE PREMATURELY RETRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396035 ↗
• InjuryJun 12, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED WHILE USING BD INTEGRA¿ RETRACTING SAFETY SYRINGE 25 G X 5/8 IN. WITH 3ML SYRINGE THE NEEDLE DID NOT RETRACT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE NEEDLE AND THE PLUNGER WENT INTO THEIR ARM. AS THIS HAD NEVER HAPPENED TO THEM BEFORE THEY WERE CONCERNED AND WENT TO THE EMERGENCY ROOM FOR X-RAYS OF THEIR ARM TO SEE IF THE NEEDLE WAS STUCK INSIDE. THE CUSTOMER INDICATED THAT THE X-RAYS WERE NEGATIVE AND DID NOT SHOW ANY PARTS OF THE MEDICAL DEVICE LODGED IN THEIR ARM. NO ADDITIONAL PAIN OR SWELLING HAS BEEN NOTICED BY THE CUSTOMER SINCE THE INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114536 ↗
• InjuryJul 14, 2022Break; Break

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE OFF INTO THE INJECTION SITE DURING THE INJECTION PROCESS. THE CONSUMER WENT TO THE URGENT CENTER AND HAD X-RAYS DONE, AND WAS REFERRED TO A SURGEON. THE X-RAYS SHOWED SOMETHING IN THE AREA, BUT IT WAS NOT STATED THAT IT WAS THE BROKEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN THE INJECTION SITE DURING INJECTION. HE STATED THAT HE WENT TO THE URGENT CENTER, HAD X-RAYS DONE AND WAS REFERRED TO A SURGEON. HE SAID THE DOCTOR TOLD HIM THAT THERE WAS SOMETHING THERE BUT DID NOT SAY IT WAS A NEEDLE. CONSUMER WAS NOT AWARE THAT THE SYRINGE IS RETRACTABLE. HE SAID THAT HE IS NOT EXPERIENCING ANY PAIN OR DISCOMFORT."

  Patient problems: Foreign Body In Patient

  MAUDE report 15013360 ↗
• MalfunctionJul 8, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD INTEGRA 3ML SYRINGE WILL NOT DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " INTEGRA STYLE SYRINGE WILL NOT DRAW UP MY MEDICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961899 ↗