BD Integra 305274Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00382903052745), received between Oct 17, 2017 and Aug 26, 2024 — classified as 5 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (15 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20069053 ↗
• MalfunctionOct 20, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE TIP OF THE PLUNGER IN THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE PIERCED THROUGH THE STOPPER DURING THE INJECTION, RESULTING IN THE PATIENT NOT GETTING A FULL DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE GIVING AN INJECTION WITH A BD INTEGRA SYRINGE, THE METAL TIP OF THE PLUNGER BROKE THROUGH THE PLUNGER STOPPER. AS A RESULT, THE PATIENT RECEIVED LESS THAN A FULL DOSE OF MEDICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643232 ↗
• MalfunctionSep 9, 2022Break

  WHILE GIVING AN INJECTION WITH A BD INTEGRA SYRINGE, THE METAL TIP OF THE PLUNGER BROKE THROUGH THE PLUNGER STOPPER. AS A RESULT, THE PATIENT RECEIVED LESS THAN A FULL DOSE OF MEDICATION. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401801 ↗
• MalfunctionJul 15, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT ON THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLUNGER WAS PUSHED TO ENGAGE NEEDLE TO RETRACT BUT INSTEAD OF RETRACTING, THE ENTIRE NEEDLE AND GREEN HUB CAME OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15035019 ↗
• MalfunctionMay 27, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE SAFETY MECHANISM DID NOT ACTIVATE.   THE FOLLOWING INFORMATION WAS PROVIDED BY THE REPORTER. DURING AN INTERVENTION WITH AN AGITATED PATIENT, WHEN IT WAS TIME TO ACTIVATE THE SAFETY MECHANISM, THE NEEDLE WAS TWISTED AND THE DEVICE DID NOT SECURE THE NEEDLE. THE PATIENT WAS VERY AGITATED AND STRUGGLING, WHICH EXPLAINS WHY THE NEEDLE WAS DEFORMED, BUT IT IS PRECISELY FOR THESE SITUATIONS THAT WE WANT SAFE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14528212 ↗
• MalfunctionApr 21, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING A 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE WITH 21 G X 1 1/2 IN., LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILST THE INJECTION WAS BEING ADMINISTERED, SOME OF THE FLUID INSIDE THE SYRINGE LEAKED FROM THE CONNECTION BETWEEN THE PLASTIC AND METAL PARTS OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176769 ↗
• MalfunctionApr 21, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT WHILE USING A 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE WITH 21 G X 1 1/2 IN., THE NEEDLE FAILED TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE USED DID NOT RETRACT FROM MUSCLE, ALTHOUGH THE MECHANISMS CLICKED AS THOUGH TO RETRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14176678 ↗
• MalfunctionFeb 7, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE NEEDLE OF THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE FAILED TO RETRACT AFTER THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INTEGRA NEEDLE DID NOT RETRACT AFTER GIVING IM INJECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476742 ↗
• InjuryFeb 1, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE RETRACTED PREMATURELY. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY HAD THREE NEEDLES THAT HAVE RETRACTED EARLY MEANING THE PATIENT HAS NOT RECEIVED THEIR FULL DOSE OF MEDICATION AND HAS HAD TO HAVE A SECOND INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417532 ↗
• MalfunctionJan 20, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE EXPERIENCED PREMATURE NEEDLE RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ADMINISTERING, INJECTION NEEDLE RETRACTED EARLY LEAVING MEDICATION LEFT IN SYRINGE.

  Patient problems: Insufficient Information

  MAUDE report 13307831 ↗
• MalfunctionJun 11, 2021Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW NEEDLE WAS JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEPOT WAS DRAWN UP WHICH MS CONSENTED TO. DEPOT WAS ADMINISTERED ON LEFT DORSO-GLUTEAL BUT CHAMBER ON RETRACTABLE NEEDLE JAMMED BEFORE FULL DOSE WAS GIVEN- ESTIMATED AROUND 0.2 LEFT IN THE SYRINGE (ACCURATE AMOUNT COULD NOT BE KNOWN AS THERE WAS A METAL CHAMBER INSIDE THE VIAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987498 ↗
• MalfunctionOct 1, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE 21 G X 1 1/2 IN. NEEDLE HAD RETRACTION FAILURES. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IM INJECTION WAS ADMINISTERED, AND NEEDLE DID NOT RETRACT ON RELEASE. EXTRA FORCE HAD TO BE GIVEN TO ENSURE NEEDLE RETRACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10614415 ↗
• MalfunctionAug 4, 2020Break; Break

  IT WAS REPORTED THAT DURING USE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE THE NEEDLE BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES BREAK WHEN PATIENTS HAVE BEEN GIVEN INJECTIONS. NO SERIOUS INJURY HOWEVER BECAUSE THE SYRINGE BROKE WHILST ADMINISTERING AN INJECTION TO THE PATIENT IT WAS IMPOSSIBLE TO ASCERTAIN HOW MUCH MEDICATION HAD BEEN ADMINISTERED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365719 ↗
• MalfunctionJun 29, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE 21 G X 1 1/2 IN. NEEDLE WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USING BD INTEGRA SYRINGE WITH RETRACTING NEEDLE. ON COMPLETION OF ADMINISTERING THE MEDICATION, A CLICK WAS HEARD AND ASSUMING THE NEEDLE HAD RETRACTED THE STAFF NURSE MOVED THE SYRINGE BACK TO DISPOSE OF IT. THE SYRINGE HAD ACTUALLY SNAPPED FROM THE END OF THE BARREL, LEAVING THE NEEDLE AND GREEN COLLAR IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10209601 ↗
• MalfunctionJun 8, 2020Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW DETACHED FROM THE NEEDLE AFTER INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A SYRINGE HAS DETACHED FROM THE NEEDLE AFTER INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10131058 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE WOULD NOT RETRACT WHEN ADMINISTERING THE DEPOT INJECTION. ADDITIONALLY, IT WAS REPORTED THAT THE PLUNGER WAS "STIFF" HALFWAY THROUGH THE ADMINISTRATION BEFORE "SHOOTING OFF" THE DEPOT INJECTION "VERY FAST", CAUSING SPILLAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE NEEDLE DOES NOT RETRACT WHEN STAFF IS ADMINISTERING DEPOT INJECTION. ON SOME OCCASIONS STAFF HAS NOTED THAT THE SYRINGE IS VERY STIFF HALFWAY, ADMINISTRATION OF DEPOT INJECTION THEN SHOOTS OFF THE DEPOT INJECTION VERY FAST CAUSING SPILLAGE. WE HAD A NEAR-MISS IN THE CLINIC WHERE THE STAFF WAS REPORTED TO HAVE ALMOST BEEN CUT/INJURED AS THE NEEDLE/SYRINGE JAMMED WHEN THEY WERE ADMINISTERING DEPOT INJECTION."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9728165 ↗
• MalfunctionJan 28, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEPOT INJECTION DREW UP FINE INTO NEEDLE, ON ADMINISTRATION THE PLUNGER MOVED QUICKLY, DEPOT MEDICATION EVIDENT ON GLOVE OF ADMINISTRATOR AND SYRINGE WOULD MOVE NO FURTHER THAN 0.5ML.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9639153 ↗
• MalfunctionJan 15, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED AFTER USE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A FEW MINUTES AGO WHEN GIVING ESTRADIOL, THE NEEDLE WOULD NOT RETRACT. JUST WANTED TO LET YOU KNOW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9594092 ↗
• MalfunctionDec 18, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF NEEDLE RETRACTION FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLES ARE NOT RETRACTING. PER PHONE CALL ON 03-DEC-2019: REPORTER STATED THAT THEIR NURSES HAVE BEEN REPORTING THAT THE NEEDLES ARE NOT RETRACTING. THEY HAVE MAYBE A 10-20% SUCCESS RATE WITH THESE BOXES. 9 VACCINATIONS TODAY AND ONLY 2 WORKED. ALSO ON OTHER OCCASIONS. UNUSED SAMPLES ARE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9491221 ↗
• MalfunctionNov 26, 2019Failure to Deliver; Difficult or Delayed Activation; Failure to Deliver; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE THERE WERE ISSUES WITH THE NEEDLE RETRACTING AND DELIVERING MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE A LARGE PSYCHIATRIC HOSPITAL AND ONE OF OUR WARDS HAS REPORTED THAT ON A SECOND OCCASION THE ¿RETRACTABLE NEEDLES WERE NOT DELIVERING THE FULL DOSE OF DEPOT, RESULTING IN INCOMPLETE TREATMENT.¿ ¿THE FAULT OCCURS WHEN ADMINISTERING THE MEDICATION, IN CERTAIN CASES THE NEEDLE RETRACTS BEFORE THE COMPLETE DOSE HAS BEEN ADMINISTERED. ADDITIONALLY IN OTHER CASES ONCE THE DOSE HAS BEEN ADMINISTERED, THE NEEDLE DOES NOT RETRACT EASILY AND REQUIRES FEW ATTEMPTS AT PRESSING THE SYRINGE TIP (LEAVING THE NEEDLE EXPOSED). THIS FAULT MAY BE OCCURRING WHEN CHANGING THE NEEDLE TIP, THIS IS BECAUSE THE NEEDLE USED WHEN DRAWING UP THE MEDICATION HAS TO BE REPLACED WITH A NEW NEEDLE PRIOR TO ADMINISTERING THE DOSE. THIS COULD RESULT IN ALTERING THE MECHANISM FOR RETRACTING THE NEEDLE. ¿UNFORTUNATELY THE WARD THAT HAD THIS ISSUE HAD DISPOSED OF THE SYRINGES SO WE CAN¿T RETURN THESE TWO YOU. WE DO HAVE OTHER UNUSED SYRINGES IN OUR STORES, AND AS A PRECAUTION HAVE QUARANTINED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9377919 ↗
• MalfunctionOct 11, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT PREMATURE RETRACTION OCCURRED DURING USE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FAULTY RETRACTABLE NEEDLE ¿ WHEN ADMINISTERING DEPOT NEEDLE STARTED TO RETRACT MAKING ADMINISTRATION IMPOSSIBLE. DRUG EVIDENT ON SKIN AND SYRINGE NOT SECURE AND AS REMOVED IT CONTINUED TO RETRACT. (NO DRUG ADMINISTERED TO CLIENT FROM THIS NEEDLE.) THEREFORE ANOTHER NEEDLE USED AND ADMINISTERED IN A DIFFERENT SITE.(NO ISSUE WITH THE SECOND NEEDLE.)"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9180584 ↗
• MalfunctionSep 18, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT HAS BEEN REPORTED THAT THE SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW HAS BEEN FOUND EXPERIENCING NEEDLE RETRACTION FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: 1)FAULTY RETRACTABLE NEEDLE. 2)RETRACTABLE NEEDLE DID NOT RETRACT LEAVING MEDICATION IN THE SYRINGE. SINCE THIS INCIDENT WE HAVE HAD ANOTHER SIMILAR CASE INVOLVING A DIFFERENT BATCH AND A DIFFERENT NURSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9082941 ↗
• MalfunctionSep 6, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT HAS BEEN REPORTED THAT THE SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW HAS BEEN FOUND EXPERIENCING NEEDLE RETRACTION FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: 1) FAULTY RETRACTABLE NEEDLE, ONLY RELEASED 200 MG OF MEDICATION INSTEAD OF 300 MG IT SHOULD HAVE 2) RETRACTABLE NEEDLE DID NOT RETRACT LEAVING MEDICATION IN THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8972082 ↗
• MalfunctionMay 30, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 4). IMPOSSIBLE TO PUSH THE PLUNGER TO THE FULL LENGTH OF THE BARREL, THE SEAL STOPPED, LEAVING 0.2MLS OF THE SOLUTION IN THE BARREL, AND THE NEEDLE DID NOT RETRACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654325 ↗
• InjuryMay 16, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE NEEDLE RETRACTED PREMATURELY AND WAS THOUGHT TO HAVE COME OUT AT INJECTION SITE WHICH LED TO MEDICAL INTERVENTION WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER THOUGHT THAT THE NEEDLE MIGHT HAVE BROKEN OFF IN THEIR BUTTOCKS. VERBATIM STATES, "FROM PHONE CALL ON (B)(6) 2019 14:39:14: I CALLED PHARMACIST BACK AND ASKED HER TO HAVE CONSUMER CONTACT US TO PROVIDE MAILING ADDRESS. PHARMACIST STATED THAT SHE DOES NOT THINK THE CONSUMER WILL PURSUE ANYTHING, SAID SHE SEEMED TO BE RELIEVED WHEN SHE DEMONSTRATED HOW THE INTEGRA SYRINGE WORKS. PHARMACIST REPORTED ON BEHALF OF CONSUMER, THAT THE INTEGRA SYRINGE NEEDLE BROKE OFF INTO THE CONSUMER'S BUTTOCKS DURING INJECTION, STATED THAT THE CONSUMER WENT TO THE EMERGENCY ROOM TO HAVE THE NEEDLE REMOVED. WHILE ON THE PHONE, THE CONSUMER'S SPOUSE WALKED INTO THE PHARMACY AND REPORTED THAT HER HUSBAND WAS TAKEN BY AMBULANCE TO THE ER, AN ULTRASOUND WAS DONE AND THE NEEDLE WAS NOT FOUND. CONSUMER WAS NOT AWARE THAT THE INTEGRA SYRINGE IS RETRACTABLE, SHE WILL BE SENDING THE SAMPLE FOR EVALUATION. NO INJURY OR DISCOMF

  Patient problems: Foreign Body In Patient

  MAUDE report 8617749 ↗