BD SafetyGlide 305904Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00382903059041), received between Nov 27, 2017 and Jul 31, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305904, BATCH#: 2131487, 4059264, 2131487, 4059264 (POSSIBLE LOTS) . RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT MALFUNCTION/FAILURE MODE: DEFECTIVE COMPONENT PRODUCT DESCRIPTION SUMMARY: I JUST HAD A CONVERSATION WITH XX. DURING AN LP PROCEDURE THIS AM THE DOCTOR WAS USING ONE OF THE SAFETY NEEDLES INCLUDED IN THE KIT WITH LIDOCAINE AND WHILE MOVING THE LIDOCAINE AROUND THE NEEDLE CAME COMPLETELY OFF THE PLASTIC SAFETY PART AND LEFT THE NEEDLE ALONE ATTACHED TO THE PATIENT. CLEARLY THERE WAS A DEFECT WITH THE NEEDLE. MFG. SKU NUMBER: 305904 INVESTIGATED COMPONENT LOT NUMBER: 2131487, 4059264, 2131487, 4059264.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676259 ↗
• MalfunctionNov 5, 2024Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20614326 ↗
• MalfunctionOct 28, 2024Break; Break

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20546079 ↗
• MalfunctionJul 27, 2023Illegible Information; Illegible Information

  IT WAS REPORTED THAT PRIOR TO USE WITH BD 3ML LL SAFETYGLIDE¿ NEEDLE THE SCALE MARKING WERE DISCOVERED TO BE DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED, SPONTANEOUS; PT REPORTED SHE WAS NOT ABLE TO USE SYRINGE DUE TO IT BEING DEFECTIVE [THE PRINTING WAS WARPED AND SHE COULDN'T READ IT]. NO MISSED DOE OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409830 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH THE BD SAFETYGLIDE¿ NEEDLE HAD ISSUES WITH THE NEEDLE AND SYRINGE SEPARATING AND ALLOWING THE DTAP-IPV VACCINE TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLIENT WAS IN FOR THE IMMUNIZATIONS. DURING THE ADMINISTRATION OF DTAP-IPV, THE SYRINGE SEPARATED FROM THE HUB OF THE NEEDLE AND VACCINE LEAKED OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857356 ↗
• MalfunctionOct 13, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB WAS DIFFICULT TO CONNECT TO THE MATING COMPONENT.  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE LEUR-LOK SYRINGE WOULD NOT TIGHTEN, THEY JUST KEPT TURNING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12626105 ↗
• MalfunctionSep 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB WAS DIFFICULT TO CONNECT TO THE LUER LOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE COMBO PACK IN THE SAME BOX, THE LEUR-LOK SYRINGE WOULD NOT TIGHTEN, THEY JUST KEPT TURNING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543723 ↗
• MalfunctionSep 13, 2021Failure to Deliver; Material Deformation; Failure to Deliver; Material Deformation

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB EXPERIENCED DIFFICULT PLUNGER MOVEMENT, AND A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FAULTY SYRINGE. WHEN PULLING BACK ON THE PLUNGER IT STOPPED HALF WAY DOWN, WRITER NOTICED THAT THE PLUNGER INSIDE THE SYRINGE WAS MISSING A PIECE FROM ONE OF ITS SIDES. THE EXTERNAL PART OF THE SYRINGE IS ALSO DENTED/SQUISHED AT THE 2 ML MARK MAKING IT SO THAT YOU CANNOT EXTEND THE PLUNGER THE FULL LENGTH. THE PACKAGING, BOX AND REMAINING SYRINGES DID NOT APPEAR TO BE DAMAGED. UNEXPECTED OR PROLONGED CARE? NO. LEVEL OF HARM: NO EFFECT. DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464805 ↗
• MalfunctionAug 11, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB EXPERIENCED FOREIGN MATTER ALONG THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRITER OBSERVED BLACK FLECKS IN THE HUB OF THE NEEDLE WHILE OPENING A COMBO PACK IN PREPARATION FOR VACCINE INJECTION. THE COMBO PACK HAD BEEN FRESHLY OPENED (PREVIOUSLY SEALED), AND THE NEEDLE PIECE HAD NOT BEEN REMOVED PRIOR TO NOTICING THE BLACK FLECKS, SO THEY WOULD HAVE HAD TO HAVE BEEN INCLUDED PRIOR TO PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305643 ↗
• MalfunctionJul 1, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE STOPPER IN THE BD LUER-LOK¿ SYRINGE WITH THE BD SAFETYGLIDE¿ NEEDLE WAS MISALIGNED. ADDITIONALLY, ANOTHER SYRINGE HAD A "CLEAR STICKY SUBSTANCE" ON THE STOPPER AT THE TOP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK RUBBER TIP ON THE END OF SYRINGE NOTED TO BE MISSHAPED AND NOT LEVEL. ONE SIDED OF THE BLACK RUBBER END APPEARS TO BE SLANTED." "PHN WAS PREPPING SYRINGE WITH AIR PRIOR TO PUTTING NEEDLE INTO DILUENT AND NOTED A CLEAR STICKY SUBSTANCE THAT APPEARED TO BE IN-BETWEEN THE TOP OF THE SYRINGE AND THE BLACK RUBBER STOPPER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099855 ↗
• MalfunctionJun 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305904. BATCH NO: 0304974. PHN WAS WITHDRAWING 1.8MLS OF SALINE FROM VIAL. PHN WENT TO REMOVE NEEDLE/SYRINGE FROM VIAL AND THE NEEDLE DISCONNECTED FROM THE SYRINGE AND REMAINED IN THE VIAL. PHN WAS GENTLE WITH VIAL AND SYRINGE AND IS UNSURE HOW THE NEEDLE DISLODGED. IT APPEARED THE GLUE HOLDING NEEDLE IN PLACE DID NOT WORK. TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055272 ↗
• MalfunctionMay 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB HAD A LOOSE NEEDLE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "WHILE USING A SAFETYGLIDE SYRINGE (3ML 25G X 5/8) THE NEEDLE POPPED OFF OF THE PLASTIC HOLDER AS I WAS TAKING THE NEEDLE OUT OF A VACCINE VIAL. THE NEEDLE ITSELF APPEARED INTACT AND UNDAMAGED WITH A BEAD OF GLUE (?) ON THE SIDE OF THE NEEDLE. NO VACCINE WAS LOST, NO PATIENT OR STAFF WERE AFFECTED. THIS NEEDLE/SYRINGE ATTACHMENT WAS DEFECTIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857960 ↗
• MalfunctionJan 5, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 1" NEEDLES WERE FOUND IN THE BOX OF BD LUER-LOK¿ SYRINGES WITH BD SAFETYGLIDE¿ SAFETY NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN ISSUE WITH ONE OF OUR PRODUCTS (MFG # 305904). WE HAVE A CASE WITH THE LOT # 9255272 THAT IS SUPPOSED TO BE A 5/8¿ NEEDLE, BUT THE BOXES ARE A MIX OF 5/8¿ AND 1¿ NEEDLES."

  Patient problems: No Patient Involvement

  MAUDE report 11121044 ↗
• MalfunctionDec 1, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 6 SYRINGES 3ML LL W/NDL SFTYGLD 25X5/8 RB EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305904 BATCH NO.: 9255272 NEEDLE WAS PACKAGED AS A 5/8" NEEDLE. THIS OCCURRED IN APPROX 6 OUT OF 50 NEEDLES IN THE BOX. CAN WE PLEASE LOG THIS CONCERN FORM IN. IT SEEMS WE ARE GETTING MFG AND LOT NUMBERS WITH SOME NEEDLES THAT ARE INCORRECT. THEY ARE ACTUALLY 1 INCH WHEN SUPPOSED TO BE 5/8TH IN.

  Patient problems: No Patient Involvement

  MAUDE report 10929623 ↗
• MalfunctionNov 19, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB CAME WITH A MIX OF PRODUCT TYPES IN A PACK. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305904, BATCH NO: 9255272. IT WAS REPORTED THAT ONE NEEDLE WAS LONGER THAN THE OTHER. EVENT DESCRIPTION PER EMAIL STATES: A NURSE TOOK TWO NEEDLES OUT FROM THE PACKAGING AND HE NOTICED ONE NEEDLE WAS LONGER THAN THE OTHER. THE LONGER NEEDLE WAS FROM LOT# 9255272. SAMPLES OF THE NEEDLES WERE NOT AVAILABLE BUT THE NURSE DID TAKE PICTURES.

  Patient problems: No Patient Involvement

  MAUDE report 10869136 ↗
• MalfunctionOct 6, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK AND INCORRECT LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305904. BATCH NO: 9255272. CUSTOMER CALLED TO REPORT THAT THEY RECEIVED A SHIPMENT AND BELIEVE THE LABELING IS INCORRECT. SHE ORDERED BD SYRINGE SAFETY GUIDE BUT BELIEVED SHE RECEIVED ANOTHER PRODUCT.

  Patient problems: No Patient Involvement

  MAUDE report 10638655 ↗
• MalfunctionJul 30, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB NEEDLE WAS STICKING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305904 BATCH NO: 9318246 IT WAS REPORTED THAT: A PIECE OF NEEDLE OR METAL STICKING OUT FROM UNDER THE OUTER CAP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10348465 ↗
• MalfunctionMay 27, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB PACKAGE WAS NOT SEALED. THIS OCCURRED ON 3 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE WAS A SILVER STRIP ON THE BACK OF THE PACKAGE AND THE PACKAGE WAS NOT SEALED AT THE LOCATION OF THE STRIP.

  Patient problems: No Patient Involvement

  MAUDE report 10094272 ↗
• MalfunctionJan 27, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE HAD "1"" NEEDLES FOUND IN THE PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OFFICE IS REPORTING THEY ARE GETTING 1" NEEDLES IN 5/8" PACKING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634502 ↗
• MalfunctionOct 7, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD SAFETYGLIDE¿ SYRINGE WITH DETACHABLE NEEDLE PLUNGERS BEND EASILY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305904 BATCH NO.: 8330741. IT WAS REPORTED THAT THE PLUNGERS BEND EASILY WITH THIS LOT. PER VERBATIM: NAME WAS SPELLED INCORRECTLY. MADE CORRECTION AND ITS A FACILITY REPORTING ISSUE. MEDICAL PROFESSIONAL REPORTED PLUNGER ARE TOO "WEAK". WITH THIS LOT. STATED, BENDING EASY WHEN TRIED FILLING IT WITH "LIDOCAINE". HAS 3 BOXES BUT ONLY USING 1 BOX. WANTS ALL 3 BOXES REPLACED, NOT COMFORTABLE CONTINUING TO USE THIS LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9161633 ↗
• MalfunctionSep 19, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. IT IS NOT SPECIFIED WHETHER THE PRODUCT DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305904, BATCH NO: UNKNOWN. CUSTOMER IS ADVISING THEY NO LONGER USE THIS ITEM DUE TO SAFETY CONCERNS WITH THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9088141 ↗
• MalfunctionSep 4, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT HAS BEEN REPORTED THAT ONE SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE APPEARS TO BE A FOREIGN PIECE OF PLASTIC IN SYRINGE. PER CUSTOMER EMAIL: REPORTED ISSUE: ONE OF THE MAS SHOWED ME A BD SYRINGE WITH MMR VACCINE DRAWN UP THAT APPEARS TO HAVE A FOREIGN PIECE OF PLASTIC IN IT. WE CANNOT BE SURE WHERE IT IS FROM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961233 ↗
• MalfunctionApr 15, 2019Leak/Splash

  IT WAS REPORTED THAT THE VACCINE LEAKED FROM THE BACK OF THE BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE AROUND THE PLUNGER DURING USE, RESULTING IN AN INCOMPLETE DOSAGE FOR THE CLIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON ADMINISTRATION OF VACCINE, VACCINE CAME OUT THE BACK OF SYRINGE AROUND THE PLUNGER INSTEAD OF GOING FORWARD THROUGH SYRINGE. CLIENT DID NOT GET FULL DOSE OF VACCINE AS A RESULT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8515296 ↗
• MalfunctionJan 31, 2019Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD LUER-LOK¿ SYRINGES WITH BD SAFETYGLIDE¿ SAFETY NEEDLES EXPERIENCED LEAKAGE DURING USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8294164 ↗
• MalfunctionDec 5, 2018Material Separation

  IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE THERE WAS AN ISSUE WITH THE NEEDLE SEPARATED FROM THE HUB AND REMAINED IN THE PATIENT. IT WAS REPORTED THAT ¿THE NEEDLE WAS REMOVED WITH THE USE OF A COTTON BALL¿.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134305 ↗