BD Integra 305283Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382903052837), received between Dec 19, 2017 and Jun 21, 2022 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2022Crack; Leak/Splash; Retraction Problem; Crack; Leak/Splash; Retraction Problem

  IT WAS REPORTED THAT THE BD INTEGRA SYRINGE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON MINIMAL PRESSING OF THE PESTLE, THE SYRINGE BROKE AND THE MEDICATION FLOWED OUT AT THE TOP AND BOTTOM. SUBSEQUENTLY, THE SYSTEM WAS ALSO DEFECTIVE. - WHAT MEDICATION/FLUID WAS USED: TEMESTA 4MG - DID A SERIOUS INJURY OCCUR? NO - DID ANY MEDICAL ACTION HAVE TO TAKE PLACE AS A RESULT OF THIS INCIDENT?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14756783 ↗
• MalfunctionDec 30, 2021Partial Blockage; Retraction Problem; Partial Blockage; Retraction Problem

  IT WAS REPORTED THAT BD SYRINGE INTEGRA 3ML LL HAD A DIFFICULT TO MOVE PLUNGER AND HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE SYRINGE PUSHED THROUGH SO THAT THE REMAINING 0.2ML COULD NOT BE INFUSED WHILE THE NEEDLE WAS STILL IN THE PATIENT'S BUTTOCK. IN ADDITION, THE NEEDLE SHOULD SHOOT BACK INTO THE SYRINGE FOR SAFETY REASONS (AFTER PUSHING THROUGH), BUT THIS DID NOT HAPPEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13121262 ↗
• MalfunctionSep 30, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE SAFETY MECHANISM FAILED TO RETRACT THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS A MALFUNCTION WITH THE NEEDLE AND IT FAILED TO RETRACT. NO HARM TO PATIENT DUE TO MALFUNCTION. DUE TO THE NATURE OF THE MALFUNCTION OF THE SYRINGE AND NEEDLE IT APPEARED THAT APPROXIMATELY 0.1 ML TO 0.2 ML OF LAI FAILED TO BE ADMINISTERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556527 ↗
• MalfunctionJun 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE INTEGRA 3ML LL LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PER PHONE CALL: HEALTH PROFESSIONAL REPORTS THAT SYRINGES ARE LEAKING. DATE, QTY, AND FURTHER DETAILS OF LEAKAGE NOT AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963789 ↗
• MalfunctionFeb 26, 2021Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE NEEDLE FAILED TO RETRACT AND HAD TO BE REMOVED BY MANUALLY RELEASING THE SPRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN ADMINISTERING AN IM INJECTION, THE NURSE NOTICED AT THE START OF THE INJECTION THAT THE PLUNGER SHOWED RESISTANCE. EXTRA PRESSURE WAS NEEDED TO ADMINISTER THE LIQUID. AFTER THE INJECTION, THE SYSTEM BLOCKED TO ALLOW THE NEEDLE TO RETRACT SAFELY. THE NURSE HAD TO REMOVE THE NEEDLE HERSELF, RELEASING THE SPRING AND NOTICING THAT SOME FLUID REMAINED IN THE SYRINGE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388483 ↗
• MalfunctionAug 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THE MEDICATION LEAKED OUT OF THE BARREL AS IF IT WAS CRACKED. PER EMAIL: I AM REACHING OUT TO YOU AGAIN, THIS TIME ABOUT AN INCIDENT WE HAD ON ONE OF OUR PATIENT CARE UNITS WHICH INVOLVED A BD INTEGRA 3 ML SYRINGE REF305283 THAT REPORTEDLY LEAKED WHILE GIVING AN IM INJECTION OF CLOPIXOL DEPOT . ACCORDING TO THE NURSE, "MEDICATION SEEPED FROM THE MIDDLE OF THE BARREL OF THE SYRINGE¿AS IF CRACKED." THE SYRINGE INFO IS: LOT 8092763CAV16 EXP 2023/03/31 SINCE THIS HAPPENED A COUPLE WEEKS AGO, I WAS ABLE TO FIND ONLY 3 SAMPLES IN CASE YOU NEEDED TO TEST THEM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10412998 ↗
• MalfunctionJun 29, 2020Break; Leak/Splash; Difficult or Delayed Activation; Break; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML LL WAS DAMAGED AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE INTERVENTION ON FRIDAY, (B)(6) IN AN EMERGENCY, THE SYRINGE BROKE, WITH THE MINIMUM PUSHING OF THE PESTLE, THE SYRINGE BROKE AND THE MEDICATION POURED OUT AT THE TOP. THEN THE SYSTEM WAS ALSO BROKEN AND THE NEEDLE FELL INTO THE SYRINGE. ANNOYING, BECAUSE THERE WAS A LOT OF POLICE ON THE MOVE AND THE POLICE AND PATIENT HAD TO WAIT A LONG TIME.

  Patient problems: No Patient Involvement

  MAUDE report 10209504 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML LL NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY INTEGRA NEEDLE SYRINGE SYSTEM. THE RN WAS GIVING A THICK OILY BASED ANTIPSYCHOTIC MEDICATION, PARTWAY GIVING THE MEDICATION, NEEDLE WAS IN THE PATIENT SKIN, THE NEEDLE HEAD DETACHED FROM THE SYRINGE, ATTACHED ONLY BY THE SPRING AND THE NEEDLE LEFT DANGLING. STATED THEY HAD PREVIOUSLY HAS A SYRINGE LEAK FLUID AT THIS SPOT BUT DIDN'T REPORT IT OR DOCUMENT ANYWHERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695375 ↗
• MalfunctionNov 27, 2019Leak/Splash; Leak/Splash

  MATERIAL NO: 305283 BATCH NO: UNKNOWN (PROVIDED 73349676CAV05) IT WAS REPORTED THAT DURING USE OF THE SYRINGE INTEGRA 3ML LL THE SYRINGE WAS LEAKING AROUND THE LUER WASTING THE VACCINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECEIVED THE ATTACHED CONCERN REGARDING 3 CASES 305283 SYRINGES WHICH ARE REPORTEDLY LEAKING AROUND THE LUER. I AM WAITING FOR THE CUSTOMER TO CONFIRM THE LOT # AS THE ONE THEY HAVE PROVIDED DOES NOT APPEAR VALID. FYI ONLY FOR NOW, I WILL UPDATED YOU AS SOON AS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9385137 ↗
• MalfunctionNov 21, 2019Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT THE SYRINGE INTEGRA 3ML LL HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LEAKAGE AT THE LUER CONNECTION HAS HAPPENED MORE THAN A DOZEN TIMES WHILE ADMINISTERING THE FLU VACCINE. PER EMAIL: THERE HAS BEEN NOTED LEAKAGE AT THE CONNECTION OF THE NEEDLE AND SYRINGE, AS OF TODAY (OCTOBER 25TH) MORE THAN A DOZEN HAVE BEEN LEAKING AT THE CONNECTION SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9355344 ↗
• MalfunctionNov 21, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD INTEGRA¿ SYRINGE LEAKED AT THE CONNECTION SITE DURING USE, REQUIRING A SECOND SHOT OF VACCINE MEDICATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE HAS BEEN NOTED LEAKAGE AT THE CONNECTION OF THE NEEDLE AND SYRINGE, AS OF TODAY (OCTOBER 25TH) MORE THAN A DOZEN HAVE BEEN LEAKING AT THE CONNECTION SITE." "BECAUSE OF THE INCIDENTS THE VACCINE WAS UNDER DOSED REQUIRING ANOTHER SHOT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354822 ↗
• MalfunctionJul 31, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848194 ↗
• MalfunctionJul 29, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A NEEDLE RETRACTION ISSUE OCCURRED DURING USE WITH A SYRINGE INTEGRA 3ML LL . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I HAVE JUST RECEIVED A COMPLAINT/CONCERN FROM ONE OF OUR CUSTOMERS ON THE INTEGRA SYRINGES (305283). THERE WERE 6 BOXES PURCHASED IN FEBRUARY, 2019. THE COMPLAINT IS THAT TWO OF THE SYRINGES HAVE SNAPPED WHEN USED ON A CLIENT. THEY DO NOT WANT TO CONTINUE USE AND HAVE EXPRESSED THEIR CONCERN. HAS THERE BEEN A RECALL ON THIS ITEM? " 2 OCCURRENCES WERE REPORTED. THE DATES, TIMES, AND PATIENT INFORMATION WERE NOT GIVEN. COSTUMER PROVIDED MULTIPLE LOT NUMBERS, BUT IS NOT SURE WHICH ARE ASSOCIATED WITH THE SYRINGES IN QUESTION. 6320741 (2 BOXES) 7146782 7334976 (2 BOXES) 5327742.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8838813 ↗
• MalfunctionMay 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BOTTOM OF THE BD INTEGRA¿ SYRINGE WHILE DRAWING UP A VACCINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT 9AM ON (B)(6) 2019, WHEN DRAWING A VACCINE, ONE OF OUR MEDICAL ASSISTANTS NOTICED THE SYRINGE PULLING THE MEDICATION AND THE FLUID LEAKING OUT THE BOTTOM OF THE SYRINGE. THIS WAS IDENTIFIED PRIOR TO REACHING THE PT. PRODUCT WAS PULLED AND REPORTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8620560 ↗
• MalfunctionApr 23, 2019Retraction Problem

  IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT WITH A 3 ML BD INTEGRA¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY INTEGRA NEEDLE FAILED TO RETRACT INTO INTEGRA SYRINGE AS IT IS DESIGNED TO DO. LEFT AN EXPOSED SHARP NEEDLE.

  Patient problems: No Information

  MAUDE report 8541246 ↗
• MalfunctionApr 22, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT 3 ML BD INTEGRA¿ SYRINGE LEAKED FROM THE HUB OF THE SYRINGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305283, BATCH NO: UNKNOWN. IT WAS REPORTED VIA MEDWATCH REPORT THAT THE VACCINE MEDICATION LEAKED FROM THE HUB OF THE SYRINGE. EVENT DESCRIPTION PER ATTACHED MEDWATCH REPORT STATES, "WHILE GIVING DTAP INJECTION I NOTICED MEDICATION SQUIRTED FROM THE HUB OF THE SYRINGE. BACKGROUND: PATIENT WAS IN FOR A 15 MONTH CHECKUP' THIS WAS A ROUTINE VACCINATION. ASSESSMENT: I INFORMED MD AND SHE ADVISED VACCINE NEEDED TO BE REPEATED, SINCE I DID NOTICE THAT ENTIRE FLUID WAS NOT ADMINISTERED. RECOMMENDATION: FATHER AGREED TO THE SECOND DOSE' HE HIMSELF NOTICED THAT ALL OF THE FLUID CAME OUT OF THE SYRINGE. PER MD RECOMMENDATION, DOSE WAS REPEATED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535901 ↗
• MalfunctionJan 11, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 3 ML BD INTEGRA¿ SYRINGE EXPERIENCED FOREIGN MATTER CONTAMINATION PRIOR TO USE.

  Patient problems: No Information

  MAUDE report 8241314 ↗
• MalfunctionJul 10, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 3 ML BD INTEGRA¿ SYRINGE FAILED, "IT APPEARS THAT THE RETRACTABLE COMPONENT HAS PIERCED THROUGH THE RUBBER STOPPER". FURTHERMORE "THE NURSE WAS NOT ABLE TO GIVE THE COMPLETE DOSE." NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Underdose

  MAUDE report 7673091 ↗
• MalfunctionJun 26, 2018Retraction Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT WITH USE A BD INTEGRA¿ SYRINGE SAFETY DEVICE FAILED AS"ON ACTIVATION NEEDLE ONLY PARTLY RETRACTED INTO SYRINGE.' THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638202 ↗
• MalfunctionFeb 7, 2018Retraction Problem; Physical Resistance; Noise, Audible

  IT WAS REPORTED DURING USE OF THE BD INTEGRA¿ SYRINGE ¿IT WAS HARD TO PUSH AND WHEN 0.2ML OF MEDICATION REMAINED IN THE SYRINGE IT MADE A CLICKING NOISE WHILE RETRACTING THE NEEDLE. WHEN REMOVED FROM PATIENTS ARM THE NEEDLE HAD NOT RETRACTED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248150 ↗
• MalfunctionDec 19, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND AROUND THE LEUR LOCK OF THE 3 ML BD INTEGRA¿ SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130769 ↗