BD SafetyGlide 305903Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00382903059034), received between Feb 28, 2018 and Jan 22, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 reports).

4 other recalls cover devices cleared under the same FDA submission (K951254); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24145440 ↗
• MalfunctionJun 10, 2024Complete Blockage; Complete Blockage

  MATERIAL # 305903 . LOT # 2258762. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE CAME OFF AFTER INSERTION WHEN TRYING TO PUSH MEDICATION." SKU: 305903. LOT - 2258762. ADDITIONAL INFORMATION PROVIDED: MY SON ADMINISTERS THE INJECTION HIMSELF SO THERE WAS NO INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL. THE ADVERSE EVENT WAS THE WASTE OF MEDICATION THAT HAPPENED AFTER THE NEEDLED CAME OFF. THERE IS ONLY A LIMITED SUPPLY OF MEDS SO ANY WASTE CAN AFFECT THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506071 ↗
• MalfunctionJan 30, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611095 ↗
• MalfunctionDec 14, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE SEPARATED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE AND SYRINGE SEPARATED WHILE THE NURSE WAS ADMIN THE VACCINE AND SHE WAS SPLASHED IN THE EYE BY THE VACCINE." ADDITIONAL INFORMATION PROVIDED ON 12/05/2023: DATE OF INCIDENT (B)(6) 2023 FULL DOSE OF VACCINE WAS NOT ADMINISTERED , REPEAT DOSE RECOMMENDED BY MODERNA SUBJECTING CHILD TO SECOND INJECTION. DO YOU WANT THE ACTUAL NEEDLE AND SYRINGE USED? IT WAS DISPOSED IMMEDIATELY BY THE NURSE. OR DO YOU WANT ONE FROM OUR INVENTORY? NO FURTHER INFORMATION PROVIDED BY REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 18325315 ↗
• MalfunctionJun 13, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING USE WITH 2 BD SAFETYGLIDE¿ THE PLUNGER WAS DIFFICULT TO MOVE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REPORTING ON BEHALF OF PATIENT, 2 RESISTANCE PUSHING PLUNGER HARM OR ADVERSE EVENTS; NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121337 ↗
• MalfunctionMar 8, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO USE WITH 7 BD 1ML SAFETYGLIDE¿ WITH ATTACHED NEEDLE THE LABELING INFORMATION WAS MISSING ON THE WRAPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THIS BOX I HAVE FOUND 7 SYRINGE/NEEDLE PACKAGES THAT ARE SEALED BUT THE WRAPPER HAS NO LABELING INFORMATION ON IT. IT IS COMPLETELY BLANK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16502856 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN A STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580962 ↗
• MalfunctionFeb 17, 2022Material Deformation; Material Deformation

  IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ 1-ML SYRINGE WITH 25-G X 5/8-IN NEEDLE A STOPPER WAS FOUND TO BE DEFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER DEFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550198 ↗
• MalfunctionFeb 17, 2022Break; Break

  IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN A PLUNGER WAS FOUND TO BE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550187 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE HAD A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " PLUNGER DEFORMED. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443624 ↗
• MalfunctionFeb 2, 2022Material Deformation; Material Deformation

  IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THE PLUNGER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "PLUNGER WAS DEFORMED AND CAN'T BE USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425264 ↗
• MalfunctionJan 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE SLIPPING OFF 305903 DURING INJECTIONS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13345229 ↗
• MalfunctionJan 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RUBBER STOPPER WAS SEPARATED FROM THE PLUNGER WHILE USING BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE CORE RUBBER STOPPER IS SEPARATED FROM THE SYRINGE BARREL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158214 ↗
• MalfunctionDec 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED LEAKAGE, AND A NEEDLE THAT WAS PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTACHING NEEDLE TO SYRINGE, THERE ISN'T A LUER LOCK TO HOLD THE NEEDLE IN PLACE ON SYRINGE DURING ADMINISTRATION. AN INJECTION TO A PATIENT IN PEDIATRICS, THE NEEDLE STAYED IN THE PATIENT WHEN WITHDRAWING THE SYRINGE. NO IMPACT TO PATIENT. SYRINGE ALSO LEAKS SINCE THERE ISN'T A LUER LOCK PRESENT AND PATIENTS MAY NOT BE RECEIVING FULL DOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006745 ↗
• MalfunctionDec 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT 2 BD SAFETYGLIDE¿ INSULIN SYRINGES WITH ATTACHED NEEDLE HAD DAMAGED, "MELTED" PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER MELTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004636 ↗
• MalfunctionDec 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "PLUNGER STOPPER WAS DEFORMED,"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921754 ↗
• MalfunctionOct 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THERE WAS FOREIGN MATTER ON THE DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLACK FOREIGN MATTER WAS FOUND IN THE NEEDLE DURING PRE-USE INSPECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715555 ↗
• MalfunctionOct 12, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "OPENED THE PACKAGE AND FOUND THAT THERE ARE BLACK IMPURITIES ON THE NEEDLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619207 ↗
• MalfunctionOct 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER DEFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616544 ↗
• MalfunctionOct 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB SYRINGE NEEDLE AND BODY SLIPPED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OCCURRED IN PEDIATRICS, THE SYRINGE NEEDLE AND THE SYRINGE BODY SLIPPED, RESULTING IN THE FAILURE TO INJECT, THE SAMPLE CAN BE RETURNED, THERE IS NO PHOTO, A GREEN CLAIM IS REQUIRED, AND A QUALITY INVESTIGATION REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580769 ↗
• MalfunctionJul 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE - WHEN INJECTING A VACCINE, IT IS FOUND TO HAVE A FLOATING SUBSTANCE INSIDE, WHICH MOVES WITH THE LIQUID. THE PROBLEM PRODUCT IS ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249931 ↗
• MalfunctionJun 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE PLUNGER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PUTTER DEFORMED PLUNGER DEFORMED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918015 ↗
• MalfunctionFeb 11, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE 1 ML BD SAFETYGLIDE" INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11316623 ↗
• MalfunctionDec 9, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT 2 ATTACHED NEEDLES ON THE BD SAFETYGLIDE¿ INSULIN SYRINGES WERE BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BROKEN".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10973454 ↗
• MalfunctionOct 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A WEIRD SITUATION WITH A SYRINGE. ONE OF THE TECHS OPENED AN 1ML SYRINGE/SAFETY NEEDLE PACKAGE AND THE SYRINGE IS CONTAMINATED WITH A BROWN SUBSTANCE IN IT. THE TECH SAID THE PACKAGE WAS CLOSED AND NOTICED THE DIRTY SYRINGE WHILE OPENING IT FOR A STERILE TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 10715224 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951254. One submission often covers many models, so check the product and lot details in each record.

• Z-2889-2020 · Jul 28, 2020 · Terminated
  BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
• Z-0315-2018 · Jul 5, 2017 · Terminated
  SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
• Z-3116-2017 · Jun 13, 2017 · Terminated
  BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from
• Z-2748-2017 · Sep 16, 2016 · Terminated
  BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below th