BD SafetyGlide 305915Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903059157), received between Feb 5, 2020 and Nov 6, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT WITH THE BD SAFETYGLIDE NEEDLE, THE SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCREASED RESISTANCE WHEN ACTIVATING SAFETY. NEEDLESTICK OCCURRED WHEN ACTIVATING SAFETY DUE TO INCREASED RESISTANCE." ADDITIONAL INFO FROM CUSTOMER: -WHAT IS THE TOTAL QUANTITY OF PRODUCTS FOUND DEFECTIVE? THERE WERE AT LEAST 2 SEPARATE OCCURRENCES IN THE SAME DAY WITH THIS PRODUCT THAT WAS NOTED TO HAVE INCREASED RESISTANCE. IS THERE ANY ADVERSE EVENT OR SERIOUS INJURY OCCURRED? A NEEDLE STICK DID OCCUR WHEN TRYING TO ACTIVE SAFETY AND THE NEEDLE CAME OFF THE SYRINGE. WHAT IS THE EVENT DATE? (B)(6) 2023. ADDITION INFORMATION PROVIDED ON 11/1/23: "REQUIRED BLOODBORNE PATHOGEN TESTING FOR BOTH MYSELF AND THE PATIENT DUE TO THE NEEDLESTICK."

  Patient problems: Needle Stick/Puncture

  MAUDE report 18075131 ↗
• MalfunctionJul 7, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ONE STRIP OF 5 NEEDLES; PACKAGE CONTAINED ONLY AIR, NO NEEDLES/CAPS. PACKAGE ALSO CONTAINS BLACK MATERIAL (DUST, WORM, GREASE, UNSURE); PRIMARILY IN ONE PACKAGE, BUT ALSO SPECKLED THROUGHOUT THE OTHER 4 ATTACHED PACKAGES. PRODUCT HAD BEEN DELIVERED TO PATIENT. ONCE DISCOVERED, SHE DISCARDED THE REMAINDER OF THE BOX OF 50 (~15 NEEDLES) PATIENT'S MOTHER REPORTS SHE HAD LOW GRADE FEVERS LAST WEEK.

  Patient problems: Fever

  MAUDE report 17283652 ↗
• MalfunctionJun 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE SFTYGLD 21X1 RB TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NURSE CAUGHT THE FOREIGN MATTER BEFORE USING ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995560 ↗
• MalfunctionDec 4, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE NEEDLE SFTYGLD 21X1 RB TW DID NOT ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY MECHANISM DID NOT ENGAGE ON THE SAFETY HYPODERMIC NEEDLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10946765 ↗
• MalfunctionDec 4, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305916 BATCH NO: UNKNOWN. A SAFETY NEEDLE ISSUE WHERE THE SAFETY DEVICE BROKE FROM THE NEEDLE AND CAUSED AN EXPOSURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10946535 ↗
• MalfunctionFeb 5, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT WHEN ENGAGING THE SAFETY LOCK ON THE BD SAFETYGLIDE¿ NEEDLE DURING USE, THE PLASTIC SAFETY COVER "SNAPPED" IN HALF. MEDWATCH REPORT# (B)(4) WAS FILED IN RESPONSE TO THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "21G NEEDLE USED TO DRAW UP MEDICATION. WHEN ENGAGING THE SAFETY LOCK ON NEEDLE, PLASTIC SAFETY COVER SNAPPED ON HALF. NEEDLE LARGELY EXPOSED DUE TO THE MOTION OF ENGAGING THE LOCK, THUMB IS MOVING UP DIRECTLY TOWARDS THE POINT OF THE NEEDLE. THIS NEEDLE WAS CLEAN, AND NO HARM DONE HOWEVER IT COULD BE VERY DANGEROUS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673379 ↗

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