BD Integra 305271Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00382903052714), received between Nov 3, 2017 and Jul 21, 2025 — classified as 21 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (38 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305271, LOT#: 2271484. RCC RECEIVED A COMPLAINT VIA EMAIL. ON SATURDAY JULY 5TH, WE RECEIVED A PRODUCT COMPLAINT VIA XXX DIRECT MESSAGE FROM A USER NAMED XXXX REGARDING A DEFECT WHILE USING A BD INTEGRA SYRINGE. ATTACHED IS A PHOTO OF THE USER¿S DIRECT MESSAGE AND PHOTOS OF THE SYRINGE¿S PACKAGING INCLUDING THE LOT NUMBER. PLEASE NOTE THAT WE HAVE RESPONDED TO THIS PERSON WITH OUR STANDARD REPLY ASKING THEM TO CONTACT THE PRODUCT COMPLAINTS TEAM BY EMAIL OR PHONE. PRODUCT#: 305271, LOT#: 2271484. HEY THERE. I'M NOT SURE IF YOU'VE HAD ANY OTHER COMPLAINTS, BUT I WANTED TO SEND A MESSAGE ABOUT THIS NEEDLE. I WAS GIVEN MY HUSBAND HIS SHOT TONIGHT, AND THIS IS THE FIRST SYRINGE/NEEDLE WE HAD GOTTEN FROM THIS BRAND. AND WHILE I WAS GIVING HIM SHOT, THE NEEDLE BROKEN OFF WHILE IN HIS SKIN. I WAS ABLE TO PULL IT STRAIGHT OUT, SO IT STAYED ON. BUT I WALKED OVER TO THE SINK TO LOOK AND SEE IF IT DID BREAK, AND IT FELL OUT INTO MY KITCHEN SINK. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561478 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Activation Problem; Adverse Event Without Identified Device or Use Problem; Activation Problem

  ADDITIONAL INFORMATION PROVIDED ON 01-MAY-2025. PATIENT ALLEGES THAT THE SUBJECT NEEDLE WOULD NOT RETRACT UNLESS SIGNIFICANT PRESSURE WAS PUT ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 21845524 ↗
• MalfunctionOct 20, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20490201 ↗
• InjuryOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL #: 305271. BATCH#: 1054566. IT WAS REPORTED THAT THE BD INTEGRA NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED PRODUCT COMPLAINT - PHARMACIST CALLED TO REPORT ON BEHALF OF THE CUSTOMER, STATING THAT THE PT ADVISED THAT THE NEEDLE GOT STUCK IN THE MUSCLE AFTER INJECTING AND THEY WERE UNABLE TO REMOVE THE NEEDLE. PT WENT TO SEE A DR. AND X-RAY WAS PERFORMED BUT THE NEEDLE COULD NOT BE FOUND. REF: (B)(4) LOT 1054566.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20457816 ↗
• InjuryOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL # 305271. BATCH # UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE PULLED OUT OF THE HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT: REF: 305271 LOT: UNKNOWN. ISSUE: USING TO ADMINISTER TESTOSTRONE WHEN PUSHING PLUNGER, THE NEEDLE CAME OUT AND WENT INTO PTS LEG. DOE: (B)(6) 2023. TAKEN TO (B)(6). DID X-RAY WAS UNABLE TO LOCATE THE NEEDLE AND A CATSCAN UNABLE TO DETECT THE NEEDLE ALL OCCURRED ON THE (B)(6) 2023. PCP SUGGESTED TO CONDUCT ULTRASOUND PTS WIFE SAID HUSBAND DOES NOT WANT TO ULTRASOUND. SAMPLE: YES, RETAINED SYRINGE IS AVAILABLE PLEASE SEND SAMPLE RETURN KIT. ADDITIONAL INFORMATION: FIRST ERROR I FOUND IN YOUR INQUIRY IS THE DATE. THE CORRECT DATE IS (B)(6) 2024 THE NEEDLE IS A BD INTEGRA SYRINGE, 3ML 23G X 1. REF: 305271, NUMBERS ON THE BOTTOM OF THE PACKAGING ARE AS FOLLOWS; (B)(4), 2026-02-28 CAV .08, LOT, 1054566. THIS SYRINGE WAS FILLED WITH 100MG OF TESTOSTERONE CYPIONATE USP 200 MG. THE NEEDLE WAS INSERTED INTO THE LEFT THIGH, THE PLUNGER WAS PUSHED TO RELEASE THE MEDICINE. THE NEEDLE RELEASED ITSELF FROM THE SYRINGE AND FORCEFULLY EMBEDDED ITSELF INTO THE THIGH.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20447272 ↗
• InjuryAug 23, 2024Protective Measures Problem; Protective Measures Problem

  MATERIAL # 305271 BATCH # 3348888 IT WAS REPORTED THAT THE BD INTEGRA "NEEDLE WAS IN THE SYRINGE". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I JUST GOT DISCHARGED AND THE NEEDLE WAS IN THE SYRINGE. THE NEEDLE IS NOT VIEWABLE TO SEE THAT IT ENDS UP IN THE SYRINGE IS ONE ISSUE, YOU CAN¿T SHAKE THE SYRINGE TO HEAR THE NEEDLE AND THE NEEDLES DON¿T HAVE AN EXPLANATION ON THEM EXPLAINING HOW IT WORKS. I GOT THEM FROM CVS AND NEVER USED THESE BEFORE. NOBODY FROM THE PHARMACY EXPLAINED THIS TO ME AND THEY DON¿T COME IN A BOX THAT EXPLAINS SO IT¿S A BIG ISSUE. THE DOCTOR AT THE ER INFORMED ME THIS HAS HAPPENED SEVERAL TIMES WHERE PEOPLE ARE COMING IN THINKING THE NEEDLE CAME OFF. IT¿S A TERRIBLE DESIGN. CUSTOMER RESPONSE ON (B)(6) 2024 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 08/03/2024 2. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? I PURCHASED NEEDLE/SYRINGE FROM CVS. THEY CAME IN A ZIPLOCK STYLE BAG AND HAD ONLY THE PACKAGE ON THE SYRINGE/NEEDLE. INSTRUCTIONS ON HOW THIS BD INTEGRA SYRINGE ARE NOT ON THE PACKAGING. I DID MY INJECTION AND THE NEEDLE WAS GONE

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20047343 ↗
• MalfunctionJul 15, 2024Defective Component; Defective Component

  MATERIALS#: 305271. BATCH#: 3272559. IT WAS REPORTED THAT THE BD INTEGRA PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WHEN RN WAS GIVING AN IM INJECTION, PLUNGER POPPED BACK OUT AND MEDICATION WAS LOST. THEN, ATTEMPTING TO RETRACT THE NEEDLE, THE NEEDLE DID NOT RETRACT AND WAS LEFT EXPOSED. UNSURE AMOUNT OF MEDICATION WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745728 ↗
• MalfunctionJul 15, 2024Retraction Problem; Retraction Problem

  MATERIALS#: 305271 BATCH#: 3272559. IT WAS REPORTED THAT THE BD INTEGRA HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: WHEN RN WAS GIVING AN IM INJECTION, PLUNGER POPPED BACK OUT AND MEDICATION WAS LOST. THEN, ATTEMPTING TO RETRACT THE NEEDLE, THE NEEDLE DID NOT RETRACT AND WAS LEFT EXPOSED. UNSURE AMOUNT OF MEDICATION WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745721 ↗
• MalfunctionApr 11, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INTEGRA HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT AN INTEGRA SAFETY NEEDLE 23G THAT DID NOT RETRACT. VERBATIM: (B)(6) HAD AN INTEGRA SAFETY NEEDLE 23G THAT DID NOT RETRACT. LOT #3325723.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093473 ↗
• MalfunctionJan 29, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602860 ↗
• MalfunctionJan 29, 2024Retraction Problem; Retraction Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602794 ↗
• InjuryJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18560092 ↗
• MalfunctionNov 17, 2023Defective Device; Defective Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166436 ↗
• MalfunctionOct 12, 2023Break; Break

  IT WAS REPORTED THAT THE NEEDLE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE OFF INTO THE BODY DURING THE INJECTION, AND COULD NOT BE REMOVED WITH TWEEZERS OR SQUEEZING. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIWEEKLY, HUSBAND IS GIVEN INJECTIONS. LAST NIGHT WHEN GIVEN THE INJECTION, THE NEEDLE BROKE OFF INSIDE THE BODY. TRIED USING TWEEZERS, SQUEEZING THE INJECTION SITE, NOT ABLE TO REMOVE THE METAL."

  Patient problems: Foreign Body In Patient

  MAUDE report 17926641 ↗
• MalfunctionAug 15, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS NOT RETRACKING POSING A RISK FOR NEEDLE STICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548468 ↗
• MalfunctionAug 11, 2023Leak/Splash; Material Puncture/Hole; Defective Component; Leak/Splash; Material Puncture/Hole; Defective Component

  IT WAS REPORTED THAT THE METAL COMPONENT IN THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE BROKE THROUGH THE STOPPER DURING THE INJECTION, CAUSING MEDICATION TO SPILL OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THEY INSERTED SYRINGE NEEDLE INTO HIP, PUSHED DOWN FOR INJECTION THE MEDICATION SPILLED OUTWARD. METAL COMPONENT WENT THROUGH STOPPER WHICH BROKE THE SEAL AND WAS NOT ABLE TO PROVIDE A SHOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17507462 ↗
• MalfunctionMay 24, 2023Retraction Problem; Defective Component; Retraction Problem; Defective Component

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PREMATURELY RETRACTED THE NEEDLE DURING USE DUE TO THE SPRING MECHANISM IN THE BARREL SNAPPING/FAILING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING 7 TOTAL FAILURES IN THE PAST 3 MONTHS, STARTING ROUGHLY (B)(6) 2023, LAST FAILURE OCCURRED TODAY, (B)(6) 2023. CUSTOMER STATES WHEN INJECTING MEDICATION, AFTER DEPRESSING PLUNGER ROUGHLY 25% OF THE WAY THROUGH, THE SPRING MECHANISM INSIDE BARREL SNAPS/FAILS, FALLS INTO THE BARREL, AND CAN NO LONGER INTERJECT. ON SOME INSTANCES, THE SYRINGE ITSELF RETRACTS AND NO LONGER STAYS IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000043 ↗
• MalfunctionMay 24, 2023Retraction Problem; Defective Component; Retraction Problem; Defective Component

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PREMATURELY RETRACTED THE NEEDLE DURING USE DUE TO THE SPRING MECHANISM IN THE BARREL SNAPPING/FAILING. THIS OCCURRED WITH 6 SYRINGES, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING 7 TOTAL FAILURES IN THE PAST 3 MONTHS, STARTING ROUGHLY 2/15/2023, LAST FAILURE OCCURRED TODAY, 5/3/2023. CUSTOMER STATES WHEN INJECTING MEDICATION, AFTER DEPRESSING PLUNGER ROUGHLY 25% OF THE WAY THROUGH, THE SPRING MECHANISM INSIDE BARREL SNAPS/FAILS, FALLS INTO THE BARREL, AND CAN NO LONGER INTERJECT. ON SOME INSTANCES, THE SYRINGE ITSELF RETRACTS AND NO LONGER STAYS IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000041 ↗
• MalfunctionMar 14, 2023Leak/Splash; Retraction Problem; Defective Component; Leak/Splash; Retraction Problem; Defective Component

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED FLUID DOWN THE PATIENT'S ARM AND WAS REMOVED. HOWEVER, WHEN THE BUTTON WAS PRESSED TO RETRACT THE NEEDLE, PART OF THE SPRING AND PLASTIC END "FLEW OFF" TO THE OTHER SIDE OF THE ROOM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADMINISTERING IM DROPERIDOL TO PATIENT USING AUTO RETRACTABLE SYRINGE. WHILE USING, FLUID LEAKED OUT OF SYRINGE AND DOWN PTS ARM, UNKNOWN HOW MUCH WAS ACTUALLY ADMINISTERED. REMOVED FROM PT BEFORE RETRACTING DUE TO OBVIOUS ISSUE WITH ITEM. ON PRESSING BUTTON TO RETRACT NEEDLE, PART OF THE ITEM (SPRING AND PLASTIC END) FLEW OFF LANDING ON THE OTHER SIDE OF THE ROOM. MANAGED TO VISUALISE NEEDLE INSIDE SYRINGE TO CONFIRM IT HAD NOT ALSO BEEN LAUNCHED ACROSS ROOM. AS PER CUSTOMER: IT IS LIKELY THAT THE NEEDLE WAS NOT CHECKED AND SECURED TO THE SYRINGE WHEN THIS INCIDENT OCCURRED AND WE ARE CURRENTLY PUTTING IT DOWN TO HUMAN ERROR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542567 ↗
• InjuryMar 6, 2023Break; Break

  IT WAS REPORTED THAT DURING USE WITH BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN. THE NEEDLE BROKE OFF AND REMAINED IN PATIENT. PATIENT WENT TO ER TO HAVE IT REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST CALLED IN AS CUSTOMER WAS USING INTEGRA SYRINGE FOR TESTOSTERONE DURING INJECTION IN GLUTEAL THE NEEDLE BROKE OFF AND REMAINED IN PATIENT. PATIENT IS ON THEIR WAY TO ER TO HAVE IT REMOVED. LOT# 0325703.

  Patient problems: Foreign Body In Patient

  MAUDE report 16492963 ↗
• MalfunctionDec 13, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.THE SYRINGE DID NOT RETRACT. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 STERILE SEALED PACKAGES AND COMPLAINED ABOUT THE NEEDLES ATTACHED TO THE INTEGRA SYRINGES WHERE NOT RETRACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972664 ↗
• MalfunctionNov 19, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN. THE STOPPER WAS DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE RUBBER STOPPER WAS SLANTED IN THE BARREL, CAUSING SOME OF THE MEDICATION TO BE LEFT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830479 ↗
• MalfunctionOct 11, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE EXPERIENCED PREMATURE NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WHEN PATIENT ATTEMPTED TO INJECT HIS MEDICATION, HE NOTICED THAT THE NEEDLE RETRACTED AS EXPECTED AFTER BEING REMOVED FROM THE SKIN, BUT THE PRODUCT REMAINED STUCK IN THE SYRINGE. HE SAYS THIS HAPPENED WITH THREE DIFFERENT SYRINGES FROM THE SAME LOT. THE MEDICINE WAS STUCK IN THE BARREL OF THE SYRINGE. IT DID NOT COME OUT OF THE NOZZLE AND THEREFORE DID NOT REACH THE NEEDLE. SO NOTHING WAS INJECTED INTO THE PATIENT'S ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583856 ↗
• MalfunctionAug 19, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHILE USING A BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE, THE NEEDLE PREMATURELY RETRACTED. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: NEEDLES WERE RETRACTING - RETRACTED WAY TO EARLY WHILE CUSTOMER WAS TRYING TO GIVE HIMSELF HIS SHOT. HE JUST BEGAN GIVING HIMSELF INJECTION AND THE PLUNGER PART SHOT THROUGH AND LOST 3/4 OF TESTOSTERONE DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260107 ↗
• MalfunctionAug 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB EXPERIENCED A COLLAPSE OF THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE BROKE IN PIECES; STATED, A "SPRING" POPPED OUT OF THE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236357 ↗