BD Integra 305270Recalls & reported problems

Summary

The FDA's MAUDE database contains 261 adverse event reports that list this exact device (DI 00382903052707), received between Jan 19, 2017 and Aug 14, 2026 — classified as 45 injuries, 216 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (123 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 25 most recent of 261 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246537 ↗
• MalfunctionAug 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246532 ↗
• MalfunctionMar 12, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24586483 ↗
• MalfunctionFeb 26, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB CAUSED LEAKAGE. RCC RECEIVED A COMPLAINT VIA EMAIL. I JUST USED A BD INTEGRA SYRINGE 3ML 25G 1" TW (0.5MM X 25MM) FOR CYANOCOBALAMIN (B-12) INJECTION INTO MY THIGH, WHICH I DO MONTHLY. I HAVE BEEN ON B-12 SINCE THE 1990S. AS I FULLY PUSHED IT IN, THIS SYRINGE LEAKED BETWEEN THE UPPER PART (NEEDLE) AND THE LOWER PART (VIAL), SPILLING ONTO MY HAND AND THE CARPET. I HAVE NO IDEA HOW MUCH I WENT INTO MY MUSCLE. MAYBE NOTHING! I TRIED TO SCAN THE QR CODE BUT WAS UNABLE. (B)(4), LOT 4304388. CRACK: NOT THAT I CAN SEE LOOSE CONNECTION: I'M NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455574 ↗
• MalfunctionJan 22, 2026Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153921 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB NEEDLE WAS BROKEN, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305270 BATCH#: 2244656. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT HE IS USING THE INTEGRA SYRINGE AND 3 NEEDLES BROKE OFF AND ARE IN HIS LEG. CUSTOMER SAID THAT HIS DOCTOR SAID HE WOULD HAVE TO HAVE SURGERY TO REMOVE THEM. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED FOR INVESTIGATION. REF#: 305270 LOT#: 2244656 ADDITIONAL INFO RECEIVED: IT WAS 3 SEPARATE INSTANCES OVER THE LAST MONTH. THE LAST ONE WAS ON DEC 27. I HAVE BEEN GIVING MYSELF SHOTS SINCE 2017-2018 WITHOUT A PROBLEM. I GOT THESE SYRINGES AND THE PROBLEMS BEGAN. I NOW HAVE 3 NEEDLES STUCK IN MY MUSCLE. CAN YOU CONFIRM IF AN X RAY WAS DONE TO CHECK FOR A NEEDLE IN THE LEG? HAS THERE BEEN ANY MEDICAL INTERVENTION SO FAR? ANY PAIN MEDICATIONS? ANY SWELLING AT INJECTION SITE OR CURRENT SIGNS OF INFECTION? ANY SURGERY DATE SCHEDULED? NONE. I FOUND OUT 2 DAYS AGO THE SYRINGE RETRACTS THE NEEDLE, SO I DO NOT BELIEVE THERE ARE NEEDLES IN MY LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153620 ↗
• InjuryDec 14, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305270; BATCH#: 2080949. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I USED A BD INTEGRA SYRINGE TO INJECT A PRESCRIBED HORMONE REPLACEMENT. I HAVE USED THEM SUCCESSFULLY FOR A COUPLE OF YEARS WITHOUT ANY ISSUES UNTIL YESTERDAY. I INJECTED MY HORMONE REPLACEMENT, AND THE NEEDLE DISCONNECTED FROM THE SYRINGE AND SHOT INTO MY LEG. THIS CAUSED A TRIP TO THE EMERGENCY ROOM, AND A CONSULTATION WITH A SURGEON WHO SAID THE NEEDLE IS EMBEDDED TOO DEEP IT THE LEG MUSCLE, TENDONS, NERVES, THAT HE FELT FOR NOW, THE SURGERY TO REMOVE IT WOULD CAUSE MORE HARM AND DAMAGE THEN JUST LEAVING IT IN. IN THE FUTURE A SURGERY MAY BE REQUIRED IF THE NEEDLE CAUSES ANY FURTHER PAIN OR DAMAGE TO THE LEG. I AM EXTREMELY UPSET BY THIS SITUATION, AS I HAVE BEEN USING THESE NEEDLES TO INJECT MY HORMONE REPLACEMENT FOR MANY YEARS WITHOUT INCIDENT. I HAVE INCURRED DISTRESS AND FINANCIAL LOSS DUE TO THIS SITUATION, AND MAY NEED A SURGERY ON THE FUTURE TO REMOVE IT. I AM REQUESTING RESPONSE REGARDING THE ACTIONS THAT BD INTEGRA WILL TAKE TO ENSURE T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23799584 ↗
• MalfunctionOct 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305270. BATCH#: 2206535. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RN WAS ADMINISTERING DECITABINE INTO RIGHT LOWER ABDOMEN. NEEDLE INSERTED THROUGH SKIN, AND PLUNGER DEPRESSED. ONCE RN PRESSED DOWN ON PLUNGER, LIQUID BEGAN TO SPILL FROM THE PLUNGER. NEEDLE RETRACTED AND PLACED ON TABLE WHERE CHEMO SPILLED ON THE TABLE. APPROXIMATELY, THREE DROPS OF CHEMO GOT ON PATIENT'S PANTS (DRIED UP WITH GAUZE.) PT INSTRUCTED TO WASH PANTS ON WITH HOT WATER/HIGH HEAT AND DRY PANTS ON HIGH HEAT. ITEM# 305270. BATCH# 2206535.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319723 ↗
• InjuryJul 11, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; MATERIAL#: 305270, BATCH#: 2356038. VERBATIM: CUSTOMER FILLED OUT AN ONLINE FORM. "ONE OF YOUR SYRINGES PUSHED A NEEDLE INTO MY HUSBAND'S ARM. I WOULD LIKE TO DISCUSS THIS." CUSTOMER RESPONSE: ON (B)(6) 2025, I GAVE MY HUSBAND AN INJECTION USING A BD INTEGRA SYRINGE (3 ML 25 G). INSTEAD OF THE PLUNGER STOPPING WHEN THE MEDICINE WAS OUT, THE PLUNGER CONTINUED UNTIL THE NEEDLE WAS INJECTED INTO MY HUSBAND'S ARM AND DISAPPEARED. HE WENT TO THE ER TO SEE WHAT COULD BE DONE. THEY CAUGHT A GLIMPSE OF IT USING AN ULTRASOUND BUT COULD NOT FIND IT ON AN X-RAY. NOW, WE HAVE A HOSPITAL BILL AND A NEEDLE FLOATING AROUND SOMEWHERE INSIDE MY HUSBAND. FROM HERE ON OUT, WE HAVE TO BE CONCERNED ABOUT THIS NEEDLE, ESPECIALLY IF AN MRI IS EVER IN THE PICTURE. SEBASTIAN WORKS A RATHER DANGEROUS JOB AND IF HE'S EVER HURT OR KNOCKED UNCONSCIOUS, WE HAVE TO BE SURE HE DOESN'T EVER HAVE AN MRI AS THE NEEDLE COULD COME OUT FROM ANYWHERE WHICH WOULD DAMAGE NOT ONLY THE MRI MACHINE BUT MY HUSBAND.

  Patient problems: Foreign Body In Patient

  MAUDE report 22480894 ↗
• MalfunctionMay 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305270 LOT # 1315713. IT WAS REPORTED BY CUSTOMER THAT THE MEDICATION LEAKED OUT OF THE SYRINGE AT THE TRU-LOK CONNECTION WITH THE NEEDLE AND ONTO THE SKIN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PATIENT SELF-ADMINISTERS CYANOCOBALAMIN (B-12) USING THE BD INTEGRA SYRINGE WITH PRE-ATTACHED BD PRECISION GLIDE NEEDLE. DURING ADMINISTRATION, THE MEDICATION LEAKED OUT OF THE SYRINGE AT THE TRU-LOK CONNECTION WITH THE NEEDLE AND ONTO THE SKIN. ADMINISTRATION WAS STOPPED, BUT PATIENT IS UNCERTAIN HOW MUCH OF THE DOSE WAS ACTUALLY INJECTED. PACKAGE, SYRINGE, AND NEEDLE ARE ALL AVAILABLE UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007046 ↗
• MalfunctionMay 12, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305270. LOT #2279988. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM(S): 305270. LOT(S): 2279988. DATE INCIDENT OCCURRED: PAST WEEKEND. WAS THE PATIENT IMPACTED? IF YES, DESCRIBE: AS THE CUSTOMER WAS INJECTING, THE PLUNGER BROKE SPILLING THE CONTENTS OF A COMPLETE VIAL OF MEDICINE. IS A SAMPLE AVAILABLE? YES & PHOTOS ATTACHED. CUSTOMER REQUEST? REQUESTS COMPENSATION FOR TESTOSERONE AND REPLACEMENT SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001296 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305270. BATCH # 4205749. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CONTACT NAME: (B)(6) CONTACT NUMBER: (B)(6) CONTACT EMAIL (IF AVAILABLE): ITEM(S): 305270 LOT(S):4205749 DATE INCIDENT OCCURRED: (B)(6) 2025. WAS THE PATIENT IMPACTED? YES. IF YES, DESCRIBE: THE NEEDLE WAS NOT ABLE TO USE NEEDLE CAME OUT AND SPRING CAME OUT. IS A SAMPLE AVAILABLE?: YES. CUSTOMER REQUEST?: PRODUCT REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955575 ↗
• InjuryJan 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL # 305270; BATCH # UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I SPOKE WITH XXX TODAY. HE ADVISED THAT HE USED THE NEEDLES A FEW TIMES SINCE THE LAST OCCURRENCE, AND THEY FUNCTIONED AS INTENDED (HE USES THEM FOR THE ADMINISTRATION OF TESTOSTERONE). YESTERDAY HE USED ONE OF THE NEEDLES AGAIN, ON THE OPPOSITE SIDE OF HIS ABDOMEN, AND THE SAME THING HAPPENED. THIS NEEDLE IS NOT EMBEDDED AS DEEP AS THE OTHER ONE AND HE SAID HE CAN FEEL IT SLIGHTLY. HE DID EXPERIENCE A BIT OF PAIN YESTERDAY BUT NOT TODAY. HE DID NOTE THAT THE TESTOSTERONE IS RATHER VISCOUS AND HE HAS TO ROLL IT IN HIS HANDS TO WARM IT UP BEFORE INJECTING IT. XXX ADVISED THAT HE TRAVELS QUITE A BIT AND IS NOT HOME AT THE MOMENT. HE ASKED THAT WE SEND HIM A LABEL FOR THE RETURN OF THE SECOND DEVICE VIA EMAIL AND HE WILL GET THE SECOND NEEDLE TO US. HIS EMAIL IS XXXX. I SENT THE PRIOR SYRINGE TO YOU TODAY BY (B)(6).  I HAVE BEEN CONTINUING TO USE THE NEEDLE TYPE, AND JUST WATCHED IT HAPPEN AGAIN.  I AM NOT GOING TO THE DOCTOR¿LAST TIME THEY COULDN¿T DO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21246195 ↗
• InjuryJan 22, 2025Break; Break

  MATERIAL # 305270. LOT # UNKNOWN. IT WAS REPORTED THAT THE BD INTEGRA NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: INTEGRA NEEDLE BROKE OFF WHEN BEING INJECTED INTO A PTS UPPER/OUTER QUADRANT OF RT GLUTEUS. HAD TO MAKE AN INCISION IN THE PATIENT TO EXPLORE THE AREA TO FIND THE NEEDLE, BUT IT WAS NOT FOUND IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21207047 ↗
• MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL #305270, BATCH #1168669. IT WAS REPORTED THAT THE BD INTEGRA NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THE NEEDLE UPON INJECTING, CAME OUT FROM THE HOUSING. BROKE OFF AND FELL DOWN. ITEM(S): BD INTEGRA SYRINGE 3ML 25G X 1. LOT(S): 1168669. DATE INCIDENT OCCURRED: 12/27/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173064 ↗
• MalfunctionJan 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057914 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WE SET IT OUT FOR PICKUP LAST WEEK. THERE HAVE NOT BEEN ANY PICKUPS. ALSO, WE HAD ANOTHER NEEDLE TODAY MALFUNCTION. I DRAW UP THE VACCINE BUT DID NOT ADMINISTER IT. AS I MENTIONED BEFORE, I THOUGHT IT WAS BECAUSE THE MACHINES WERE NOT TIGHTENING THE NEEDLE TO THE SYRINGE PROPERLY. THAT IS NOT THE CASE. THIS NEEDLE WAS SCREWED IN PROPERLY, BUT IT STILL LEAKED VACCINE AS I WAS TRYING TO GET THE AIR BUBBLES OUT. DO YOU WANT ME TO ADD THE NEW SYRINGE TO THE SHIPMENT? I CAN LABEL EACH SO THERE IS NO CONFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032724 ↗
• InjuryDec 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL#: 305270. BATCH NUMBER#: 4214080. IT WAS REPORTED THAT THE BD INTEGRA NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM(S): BD INTEGRA SYRINGE WITH PRECISION GUIDE NEEDLE 3MM 25G X1 INCH LOT(S): 4214080. DATE INCIDENT OCCURRED: (B)(6) 2024. WAS THE PATIENT IMPACTED? YES. IF YES, DESCRIBE: SYRINGE DEFECTIVE. PATIENT ATTEMPTED TO INJECT 0.5ML OF TESTOSTERONE BUT THE NEEDLE BLEW STRAIGHT OUT OF THE HUB OF THE SYRINGE. NEEDLE WENT COMPLETELY INTO CUSTOMER¿S HIP. RUSHED TO ER AND WILL NOW BE SEEING A SURGEON ON TUESDAY TO SCHEDULE TO HAVE IT REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21000065 ↗
• InjuryDec 21, 2024Break; Break

  IT WAS REPORTED THAT THE BD INTEGRA NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT NEEDLE BROKE OFF VERY PAINFUL BRUISING WITH A NODULE RCC RECEIVED A COMPLAINT VIA EMAIL. HAS AN EMERGENCY BILL NEEDLE BROKE OFF VERY PAINFUL BRUISING WITH A NODULE. CONTACT NAME, NUMBER AND EMAIL: (B)(6). ITEM(S): SYRINGE NEEDLE. ADDITIONAL INFORMATION PROVIDED: THE DATE THIS HAPPENED WAS (B)(6) 2024 LOT NUMBER IS 2349876 FOR THE BD INTEGRA SYRINGE 3ML 25GX 1. THERE WAS BRUISING AND TENDERNESS THAT LASTED 5 OR 6 DAYS. HELLO I HAVE ATTACHED A PIC OF THE SYRINGE THAT THE EMERGENCY ROOM DISTRICTED LOOKING TO SEE IF THE NEEDLE WAS INSIDE. I ALSO HAVE A PICTURE OF THE PACKAGE AND THE LOT NUMBER. ALSO A PIC OF ONE OF THE NEEDLES COMPLETELY IN-TACKED.

  Patient problems: Pain

  MAUDE report 20996698 ↗
• MalfunctionDec 16, 2024Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20947873 ↗
• MalfunctionNov 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL: 305270. BATCH#: 4214081. IT WAS REPORTED THAT THE BD INTEGRA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. (B)(6). RESIDUE INSIDE THE SYRINGE. REF: (B)(4). LOT 4214081. SAMPLES ARE AVAILABLE. CUSTOMER WOULD LIKE TO KNOW IF THEY CAN USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768677 ↗
• MalfunctionNov 7, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630195 ↗
• MalfunctionNov 7, 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 20630183 ↗
• MalfunctionNov 7, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630157 ↗
• MalfunctionNov 7, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630143 ↗